Frontida is actively recruiting innovative and caring professionals. Here, you can help develop and build a culture of caring, accountability and continuous improvement (both individually and corporately). Frontida careers extend from pharmaceutical formulation scientists to quality assurance specialists, information technology to regulatory compliance professionals, and manufacturing to mechanical specialists. Join a powerful, results-oriented team.

Job Summary

Oversees, the development, implementation, compliance, reporting and monitoring of the Company’s environmental, health and safety (EHS) programs. Overall responsibility to ensure Company standards & regulatory requirements are met with respect to the safe operation of the company facilities.

 

Responsibilities

  • Ensures compliance with applicable federal, state, and local regulations as well as company policies.
  • Compiles and submits all required reports to local, state and federal authorities. Compiles and maintains accurate recordkeeping for all regulatory agencies including OSHA, EPA, DEP, DOT, etc.
  • Responsible to see that lost time and OSHA recordable safety goals are met. Oversees and maintains day-to-day safety programs at the company’s facilities.
  • Coordinates the investigation of incidents as necessary, reviews, approves incident reports.
  • Evaluates potential workplace hazards and ensures that ongoing programs/remedies are implemented.
  • Promotes the safety program and strongly influences employees and management teams throughout the organization, by developing, implementing and maintaining general company safety policies and procedures to ensure regulatory compliance and promotion of company objectives.
  • Inspects (audits) organization facilities to detect existing or potential safety and health hazards, and recommends and implements corrective or preventative measures, and follows up to ensure measures have been implemented.
  • Advise management on health and safety issues and recommend ways to improve the safety of our operations. Follows up with departmental management to ensure that recommendations are implemented as required.
  • Develops training policies, programs, and schedules, selects or develops teaching aids such as training handbooks, demonstration models, multimedia visual aids, computer tutorials, and reference works and conducts training sessions.
  • Communicate Safety & Health requirements and assist departments in implementing responsive programs, promote and encourage the safe utilization of equipment and facilities.
  • Chairs and directs the safety committee.
  • Represents the company to governmental inspectors, insurance companies, and contractors as appropriate.
  • Provides safety assessments for proposed research products. In the absence of published OEL or TWA, sets limits based on scientifically-defensible techniques and data.
  • Maintains and monitors the following and other programs as necessary: MSDS Database, fire extinguishers, hazardous and non-hazardous waste handling, respirator training, safety glasses, etc.
  • Provides and administers training for fork truck, confined space, violence in the work place, blood borne pathogen, fire extinguisher, HAZCOM, PSM, Lock-out/tag out, confined space, CPR, respirator & respirator fit test, hot work, incident/accident, DOT, IATA, HAZWOPPER, etc. This includes new employee  and contractor safety orientation and training.
  • Ensures proper safety apparel, equipment and services are provided, i.e. Safety Shoe and Glasses programs, etc.
  • Provides or arranges industrial hygiene services where appropriate.
  • Coordinates workers’ compensation program, including working with the employee, insurance carrier and medical providers regarding appointments, lost-time, restrictions, etc. also maintains safety files and records
  • Other duties may be assigned.

Qualifications

• Bachelor’s Degree in Chemical Engineering, Safety Engineering, EH&S Management or related field. Professional certification is a plus.
• Five plus years of experience, in a manufacturing environment required, Chemical or Pharmaceutical industries a plus. Previous experience with pharmaceutical solid dosage manufacturing and managing a staff in a cGMP regulated environment.
• Must have thorough and demonstrated knowledge and experience with federal, state and local Safety & Health regulations, including DOT, OSHA, etc.

Knowledge and Skills

  • Experience in development, organization and implementation of facility-wide, safety programs.
  • Demonstrated ability to recognize, evaluate, and recommend controls for workplace hazards.
  • Demonstrated ability to determine training needs, organize and/or conduct training. Excellent written and oral communication skills.
  • Computer literate and proficient with Microsoft office suite and applicable applications related to perform the Safety Coordinator function.
  • Strong communication skill.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

For a contract manufacturing organization (Frontida BioPharm, Inc. – Philadelphia, PA): perform method development, verification and validation for drug products and raw materials using various analytical procedures and dissolution techniques; perform reverse engineering for generic products; optimize procedures of analytical methods; investigate abnormal results; operate and troubleshoot GC, HPLC, UPLC, UV/Vis and FT-IR.

 

Work Location: Philadelphia, PA.

Hours: 40 per week – Monday through Friday

To apply online.

Qualifications

Requirements:

  1. Master of Science or foreign equivalent degree in Chemistry, Analytical Chemistry or a related field.
  2. 2 years experience in job offered or 2 years experience as a Research Scientist in the pharmaceutical industry.  This required experience must include 1 year experience in generic products development (suspension, injectable, tablets, capsules), small scale per cGMP procedures and manufacturing processes optimization, and 1 year experience in reverse engineering for products and analytical method development/validation using HPLC, LC-MS/MS, UPLC, GC, GC-MS, fluorescence, XRD and particle size analytical techniques, including Mastersizer and Zeta Potential.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Responsible for the documentation, installation, calibration/verification/qualification, preventive maintenance, and repair of a wide variety of scientific instruments used at AR&D, Frontida Biopharm, Inc., including but not limited to: HPLC, UPLC, GC, UV/Vis, FTIR, dissolution, particle size analyzers, etc.

Responsibilities

  • Calibrates/verifies/qualifies and performs preventative maintenance on laboratory equipment which include, but are not limited to, HPLC, UPLC, UV/Vis, GC, dissolution, FTIR, particle size analyzers, etc.
  • Inspects, evaluates, troubleshoots, and repairs laboratory equipment when problems arise.
  • Documents, reviews, and audits calibration/maintenance/repair activities of laboratory equipment.
  • Maintains calibration/maintenance schedules to keep the Calibration Program up-to-date.
  • Completes all work in a safe and efficient manner in accordance with cGMP and GLP requirements.
  • Maintains and archives calibration/maintenance/service records in Blue Mountain RAM.
  • Assists in the installation, operation, and performance qualification (IQ/OQ/PQ) of laboratory instruments.
  • Installs/re-installs, disassembles, cleans and makes necessary modifications to various instruments.
  • Records and reports out-of-tolerance results and any other instrument-related issues to the manager and performs corrective actions as directed.
  • Arranges for vendor service when necessary.
  • Maintains inventory and researches options on prices and availability of parts.
  • Works closely with users and external groups to help operate instrumentation and develop techniques that will meet the needs of the user community.
  • Participates in writing SOPs, protocols, and instrument validation plans.
  • Aids in laboratory investigations due to instrument-related issues when needed.
  • Explores ways that maximize efficiency at lower costs.
  • Must participate and successfully complete all company training, as required.
  • Performs other duties as assigned.

Knowledge and Skills

Bachelor’s degree in Chemistry or Associate’s degree (A. A.); one to two years related experience and/or training; or equivalent combination of education and experience. Calibration/ Maintenance/Service certifications in lab equipment are preferred. Knowledge/skill/experience in the operation of various laboratory instruments is required. 1-2 years of HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR, and/or Particle Size Analyzer calibration, maintenance, and/or repair experience is preferred. Previous experience in the pharmaceutical industry highly desirable. Must have good communication and technical writing skills. Proficiency in Microsoft Word, Excel, and Outlook and the ability to learn other software applications, as required. Experience with Blue Mountain RAM is preferred.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The QA Associate will be responsible for supporting compliance activities for GxP operations. The QA Associate will be responsible for a diverse and challenging set of activities related to setting and maintaining quality standards aligned with FDA cGMP regulations.

 

Work location: Aurora, IL (relocation assistance is not provided)

Responsibilities

Review and approve Deviations, CAPAs, investigations, complaints

Auditing Responsibilities

  • Audit all areas of production for adherence to cGMPs.
  • Perform and participate in internal audits and facility inspections.
  • Support and participate in regulatory audit preparedness and during inspections by regulatory agencies.

Calibrate QA and/or production equipment.

Support QA Associate III in executing cleaning validation, purified water and environmental monitoring programs

Knowledge and Skills

Requires a Bachelor’s degree in any life science, preferably in Chemistry and/or Biology. The various QA Associate II levels require the following experience in a regulated environment in Quality Assurance, Quality Control, Compliance, or Manufacturing with 2 to 4 years’ experience.

The candidate must have training in cGMPs and/or cGxPs and relevant regulatory guidelines. Must be familiar with relevant regulations; formal training and/or advanced courses are preferred. Must have excellent interpersonal skills and the ability to communicate company policies and procedures clearly.

Must have strong organizational and record keeping skills, and the ability to handle multiple projects. Ability to work independently in fast-paced environment with little supervision. Ability to adapt to contact change and work effectively in abstract environment. Candidate must be motivated and detail-oriented. Proficient at mid-level in Microsoft Office applications (Word, Excel, Outlook), data management systems and business related application packages highly desired, plus the ability to learn company used applications.

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

We are seeking an experienced senior scientist to join our Formulation team at our Philadelphia location. The candidate will be responsible for the development and evaluation of new formulations and/or formulation platforms of complex pharmaceutical products such as controlled release, solid oral dosage forms, etc under minimal supervision using established and novel technology.

Responsibilities

  •  Performs in-depth, detailed and complex literature and patent searches to provide background basis for development plans
  • Plans, executes, and assists in the evaluation of formulation development activities
  • Utilize experimental design to rapidly optimize formulation composition and in-process specifications
  • Evaluate product testing results, provide next steps for continued development until finalize product formulation and processes
  • Present product development progress to upper management and project teams
  • Troubleshoot formulation issues that occur during product development, scale-ups and/or in production
  • Develop new formulation concepts. Assists in the development of project plans and business analysis and feasibility assessments
  • Writes, reviews, and approves cGMP documentation including batch records, protocols, SOPs, pharmaceutical development reports etc.
  • Advances process technologies and supports the patent (intellectual property) development
  • Provides mentoring to Formulation Scientists
  • Effectively communicate with cross functional teams like Analytical Development, Quality, PK, Regulatory Affairs and Legal teams
  • Attend SOP, Safety and scientific trainings to remain current with CGMP regulations, safety standards, and development technologies
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

  • Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry or Chemical Engineering with 3 years of experience or a Master’s degree with 5 years’ experience is preferred. Experience with generic drug development is desirable
  • Good understanding of pharmaceutical formulation development principles, QbD, CMC regulation and strong organization skills
  • Excellent written and oral communication skills, critical thinking and interpersonal skills

Knowledge and Skills

  • Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development
  • Proven experience with statistical design of experiments
  • Strong written and oral communication skills
  • Working knowledge of regulatory requirements, including FDA, EMEA, ICH, and regulations in regards to IIG, GRAS, residual solvents, bioequivalence studies, etc for oral formulations
  • Working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent
  • Ability to present technical presentations to management to ensure understanding, responding to complex questions
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The successful candidate will be accountable for overall management of assigned projects with goals of timely project completion, adherence to project budgets and contracted activities, and client satisfaction.  The Project Manager will be responsible for resource planning for each project in coordination with operational leadership.  This person interfaces with every department internally and with client representatives having various functions including, but not limited to: Formulation and Analytical R & D, Business Development, Finance, Regulatory Affairs, QA / Compliance, Quality Control, Logistics and Manufacturing.

Responsibilities

  • Provides oversight and direction to ensure execution and delivery of all assigned projects on time and within budget.
  • Motivates the project team to achieve project objectives through successful completion of project tasks.
  • Effectively prioritizes and coordinates the activities of the team.
  • Arbitrates and resolves issues, conflict and interface problems within the project team and between functional partners and stakeholders.
  • Works closely with the clients and management/departmental leaders to overcome obstacles to project success. Negotiates additional project

 

scope / activities with clients when changes are requested or required to progress projects forward.

  • Assures effective project team and internal/external communication, keeping all informed of progress and issues in order to manage expectations on all project requirements and deliverables. Assures that project documentation is kept current, clear and transparent and is communicated as appropriate. Writes project scope, work orders, budgets / proposals in order to ensure client compliance and involvement in the project outcomes.
  • Escalates key decisions, issues, risks and opportunities as required to achieve project objectives.
  • Helps to manage and build relationships with external partners, e.g., vendors, as appropriate.
  • Represents projects at required internal and external meetings to assure that priorities are communicated and understood, and that progress/delays/issues are reported.
  • Assists Business Development team to prepare proposals.
  • Manages existing client relationships and identifies new project opportunities through continual interaction and solicitation through periodic follow-up or routine project communications.
  • Must participate and successfully complete all training as required by the company.

Qualifications

• Bachelor’s degree in a technical field or business with 3-5+ years related project management, R&D, and/or manufacturing experience (drug substance or drug product) or equivalent combination of education, training, and experience.
• Previous experience with pharmaceutical solid dosage, liquid or topical manufacturing and working in a cGMP regulated environment.

Knowledge and Skills

• Strong communication, organizational, and project management skills.
• Capable of making quick assessments; taking corrective action using good judgment and appropriate decision making steps.
• Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications. Knowledgeable in MS Project and JMP software highly desired.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers and facilitate resolution of issues that may arise.
• Ability to effectively present information to both in-house and external top management.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Effective leader under time pressure, team player, accurate and patient.

 

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

The Account Executive is responsible for proactively identifying and evaluating business opportunities that will effectively support the company’s revenue and profit goals.  The position requires knowledge of the brand and generic pharmaceutical marketplace and a successful track record in business development or sales.  The successful candidate must have demonstrated success in identifying market trends and ideas for growing revenue. The successful candidate will join an experienced and sophisticated business development team who compete aggressively in the market while maintaining a collaborative internal culture.  This role is best suited to those who thrive on using their existing relationships to develop creative solutions to build a sustainable revenue stream and are able to propose market segments that will be complementary to the current base business.  The position may require travel at least 30% of the time.

Responsibilities

  • Primarily responsible for driving sales growth with regional and national accounts for new product development, clinical and commercial supply
  • Financial accountability for the achievement of new products revenue, deals signed and delivering pipeline & sales funnel targets.
  • Identifying new clients, initiate contact and close opportunities
  • Prepare, present, negotiate technical pricing proposal for product development, clinical and commercial supply, in coordination with Senior Management, R&D, Contract Management, Legal
  • Conduct technical feasibility of potential new business project, and follow up with missing pertinent data for quotation.
  • Must be prepared to present quotation analysis to all levels of the organization
  • Manage the day-to-day requirements of the business relationship including pricing, contracts, forecasting, periodic business review, and additional items as necessary
  • Participate in internal process teams, conferences, trade shows, marketing campaigns, and professional associations as required.
  • Exceptional client service and account management by managing the day-to-day client activities across a variety of work streams and accounts
  • Represent the company in a professional manner at industry meetings while promoting the brand and generic business. This will include presenting product features and benefits to a targeted trade class of customers

Qualifications

  • Bachelor’s degree coupled with 5+ years of Sales Management experience in the generic or branded pharmaceutical marketplace. MBA Degree is preferred.
  • Established relationships with R&D and Commercial phase Rx pharmaceutical companies
  • Must have past experience developing and executing against customer strategies
  • Must be able to work autonomously and demonstrate superior leadership disposition (poise, business acumen, results orientation and good judgment.
  • Blend of sales and marketing background preferred
  • Strong computer skills, including Microsoft Word, Excel, and PowerPoint.
  • Ability to work effectively in an entrepreneurial environment
  • Balanced work style allowing for equal success whether working independently or collaborating with the team
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

 

Machine Operator performs a wide variety of activities required to produce high quality pharmaceutical products.

Responsibilities

 •By following relevant SOP’s/Batch record instructions the operator will be responsible for performing and documenting the following activities:
• Serial/complete cleaning of product rooms and granulation equipment such as mills, mixers, ovens, etc.
• Operation of granulation equipment
• Weighing/compounding of Mutual Pharmaceutical Company products in accordance with current Good Manufacturing practices.
• Safety equipment such as respirators (PAPR), gloves, safety shoes are required.
• Must participate and successfully complete all training as required by the company.
• Perform other duties as assigned.

Qualifications

  • High School diploma or equivalent GED
  • 3+ year experience in Manufacturing. Pharmaceutical Industry experience preferred.
  • Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers and other employees of the organization.
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Knowledge and Skills

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit, use hand and fingers, to manipulate objects, tools, or controls; and reach with hands and arms. The employee is occasionally required to stand, walk, stoop, kneel, crouch, or crawl, and talk or hear.

The employee must regularly lift and/or move up to 20 pounds, frequently lift and/or move up to approximately 65 pounds. Specific vision abilities required by this job include close vision, color, peripheral, depth perception and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee is frequently required to work in a manufacturing environment. The noise level in the work environment is usually moderate.

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Applies engineering principles to design, modify, or develop facilities, testing, machines, equipment, or processes used in the processing, testing, manufacturing, and packaging of pharmaceutical products by performing the following duties.

Responsibilities

  • Analyzes product or equipment specifications and performance requirements to determine designs that can be produced by existing manufacturing or processing facilities and methods.
  • Analyzes engineering proposals, process requirements, and related technical data pertaining to facilities and equipment.
  • Manage all aspects of capital projects, as required, from conception to completion, including budgets, documentation, scheduling, and contractors.
  • Author, manage, and execute all aspects of required Qualification and Computer Validation Documentation as it relates to facility, equipment and/or computer systems.
  • Determines feasibility of designing new plant equipment or modifying existing facilities considering costs, available space, time limitations, company planning, and other technical and economic factors.
  • Provides technical information concerning manufacturing or processing techniques, materials, properties, and process advantages and limitations which affect long range plant and product engineering planning.
  • Compiles and analyzes operational, test, and research data to establish performance standards for newly designed or modified equipment.
  • Studies engineering and technical publications to keep abreast of technical changes and developments in industry.
  • Uses computer assisted engineering and design software and equipment to perform engineering tasks.
  • Provides technical expertise and assistance to the Facilities & Engineering Department for troubleshooting and investigating equipment, facility, and cGMP related issues, including updating documentation, instituting procedures, and authoring/executing qualifications.
  • Perform other duties as assigned.

Qualifications

  • Bachelor’s degree (B. S.) in Engineering (Mechanical preferred).
  • Three plus years related experience in an industrial manufacturing environment.
  • Prior pharmaceutical industry experience is a preferred.

Knowledge and Skills

  • Good written and oral communication skills.
  • To perform this job successfully, an individual should have knowledge of Design software; Project Management software; Spreadsheet software and Word Processing software. Proficient in Auto Cad.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

We are seeking an experienced scientist to join our Formulation team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation and manufacturing process development by performing formulation development activities for both ANDA and NDA projects.

Responsibilities

  •  Design and develop formulations and processes for new drug products with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
  • Utilize experimental design to rapidly optimize formulation composition and in-process specifications
  • Evaluate product testing results, provide next steps for continued development until finalize product formulation and processes
  • Present product development progress to upper management and project teams
  • Write CGMP manufacturing batch record, stability study protocol, in-process and finished product specifications and product development reports
  • Manufacture development, optimization and scale-up batches and submission batches
  • Troubleshoot formulation issues that occur during RD development, scale-ups and/or in production
  • Effectively communicate with cross functional teams like Analytical Development, Quality, PK, Regulatory Affairs and Legal teams
  • Attend SOP, Safety and scientific trainings to remain current with CGMP regulations, safety standards, and development technologies
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

  •  Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry or Chemical Engineering with 0-2 years of experience or a Master’s degree with 3 years’ experience is preferred. Experience with generic drug development is desirable
  • Good understanding of pharmaceutical formulation development principles, QbD, CMC regulation and strong organization skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

This position is for our manufacturing facility in Aurora, IL.

Machine Operator performs a wide variety of activities required to produce high quality pharmaceutical products.

Responsibilities

  •  Manufacturing activities include, but are not limited to: setup, operation, cleaning and troubleshooting of equipment and facilities.
  • Unit operations include: granulation, blending, compression, milling and fluid bed processing.
  • Promotes quality assurance through leadership and example.
  • Provides suggestions for improved efficiency and quality within the manufacturing department.
  • The position requires a high degree of attention to detail and an ability to think critically.
  • Employee needs to have basic understanding of tools and have a basic mechanical aptitude.
  • Understand company goals and objectives and apply them to everyday tasks.
  • Able to work flexible schedule and work extended hours on short notice when necessary.
  • Perform other duties as assigned.
  • Perform other duties as assigned.

Qualifications

  • High school diploma or (GED )with 2-4 years manufacturing experience. Pharmaceutical or Food Industry experience preferred. OR Associate’s/BS degree in Science with 0-3 years of relevant experience. Pharmaceutical or Food Industry experience preferred.
  • Excellent interpersonal and communication skills are essential in this collaborative work environment
  • High degree of professionalism, ethics and integrity
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.