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

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

The GMP Training System Specialist is responsible for managing the administrative functions of the training system for the Philadelphia locations.  This includes managing job codes, exams, on-the-job training (OJT) documentation and increasing the use of the LMS system functionality to support the site operations and compliance.

Responsibilities

  • Supporting the conduct of effective new employee orientation sessions in a timely manner
  • Process training related tasks and documents through applicable EQMS systems in a timely manner
  • Communicate to job code owners, SOP authors and other key stakeholders when tasks are required of them such as exam writing, review and approval, job code evaluation and task initiation. Drive timely completion by stakeholders to support procedure approval timelines
  • Write or revise exams for new and revised procedures in a timely manner
  • Support authors of SOPs in writing and revising exams
  • Manage Job Code organization and structure to ensure employees are trained appropriately, job codes are organized to support the departments and OJT is reflected in the EQMS where possible
  • Generate reports of pending and overdue training including monthly metrics as requested
  • Assist departments who require On-the-Job (OJT) training to manage the structure and documentation of such training as applicable, e.g., lab modules, manufacturing OJT
  • Other assigned administrative tasks as required in keeping the company compliant with cGMP, industry standards and regulations (e.g., organizing and filing paper-based training records, managing electronic copies of training records on shared drives and in the LMS, etc.)

Qualifications

  • Bachelor degree in education or relevant field with 1-2 years in training or a bachelor degree in a life science with 2-5 years in training
  • Pharmaceutical experience is preferred
  • Strong communication skills
  • Experience in using and managing an electronic learning management system
  • Strong writing skills and record keeping ability for reports and training manuals
  • Good computer and database skills
  • Works well across all departments and functions

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

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

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

The Compliance Specialist  will be responsible for managing the vendor qualification program, conducting performing annual product reviews, collecting metrics across the company, and preparing reports for monthly quality council/management review meetings and other technical reports common to the Compliance Department.

Responsibilities

  • Collects metrics across the company for trending of quality performance
  • Performs annual and quarterly trend reports
  • Authors and reviews Annual Product reviews
  • Performs internal audits to ensure compliance against procedures and regulations
  • Performs external audits for suppliers and service providers
  • Manages the vendor qualification program
  • Provides support for execution of special quality projects to implement quality systems, improvements to meet regulatory requirements
  • Provides support during FDA and other regulatory body inspections
  • Updates Standard Operating Procedures (SOP)
  • Supports other departments as directed which may include:
    • Conducts investigative analysis of non-conformance events in the Quality Control laboratory
    • Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis

Qualifications

  • Bachelors Degree in a lie science such as Chemistry, Microbiology, Biology or related scientific field supplemented with 2-4 years Quality Experience in pharmaceutical industry.
  • Some knowledge of cGMP, FDA and OCHA regulations.
  • Proficiency in Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages.
  • Experience with Quality Event Management software

 

Knowledge and Skills

  • Strong analytical skills, with an ability to use scientific knowledge and statistical methods to identify potential problems and trends.
  • Ability to organize and write scientific reports
  • Good project management skills
  • Strong computer skills and knowledge of word processing software and spreadsheet software
  • Competent in leading meetings, investigations and team projects
  • Competent in pharmaceutical compliance and regulatory policies
  • Knowledge of pharmaceutical industry guidelines, trends and practices
  • Act with professionalism and treat others with respect and consideration regardless of their status or position
  • Ability to gather information from multiple sources and coordinate and analyze their impact on each other
  • Previous completion of cGMP training

 

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

SUMMARY

Performs a wide variety of activities required to produce high quality pharmaceutical products. Schedule for this role is second shift.

 

 

 

Responsibilities

ESSENTIAL FUNCTIONS

  • 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 Manufacturing department
  • Understand company goals and objectives and apply them to every day tasks
  • Able to work flexible schedule, and work extended hours on short notice when necessary
  • Perform at line in-process testing such as
    • Loss on drying
    • Particle size distribution
    • Bulk and tapped density
    • Tablet hardness, thickness, and friarbility
  • Perform other duties as assigned

Qualifications

REQUIREMENTS

  • High degree of attention to detail and ability to think critically
  • Basic mechanical aptitude
  • HS Diploma or GED With minimum of 2 years manufacturing. Pharmaceuitical and/or food industry highly preferred
  • Associates or BS plus a minimum of 1 year manufacting experience in Pharmaceutical or food industry

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.

We are seeking a Manager of Manufacturing to join our team! You will oversee the activities of a team of production workers. 

Responsibilities

  • Manages staff and carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, terminating and training employees; planning, assigning, and directing work; appraising performance; counseling employees; addressing complaints and resolving problems.
  • Organize shift schedule to meet production demands. Use and Maintain electronic schedule using Microsoft Project Central or similar tool.
  • Assign operators job responsibilities on daily basis
  • Ensure that necessary materials and supplies are available to facilitate the operators completion of daily job responsibilities.
  • Ensure that operators’ actions are consistently performed with a “safety” minded attitude and are within guidelines determined by cGMP, SOP and Company policy.
  • Support, direct and train operators during the performance of their daily job responsibilities. Support, direct and train materials management personnel during the performance of their daily job responsibilities. Use Electronic Inventory Management and Batch Planning tools as required.
  • Evaluate, review and audit operators performance and work environment for “safety”, cGMP, SOP and Company policy compliance.
  • Work with the maintenance department in order to ensure that the process equipment and supporting machinery are properly maintained. Generate maintenance work tickets as required.
  • Work with the Quality Department to ensure that Quality issues are resolved in a timely manner. Use Electronic Quality Management systems as directed by SOP.
  • Ensure that the BMR (Batch Manufacturing Records) are completed on time and correctly.
  • Must participate and successfully complete all training as required by the company. Create, modify and maintain SOP’s for manufacturing activities.
  • Assist in authoring and reviewing Process Development reports, BMR’s and Protocols.
  • Perform other duties as assigned.

Qualifications

  • B.S. degree in Business, Pharmacy, Chemistry, Engineering with 2+ years’ pharmaceutical manufacturing experience or equivalent combination of education, training and experience.
  • Ability to operate related manufacturing equipment.
  • Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications
  • Strong leadership qualities
  • 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) and business related application packages highly desired, plus the ability to learn company used applications
  • 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

Compliance Specialist is responsible for administering GMP computer systems used in Quality Control and support computer systems validation projects. Time permitting, also support Compliance department responsibilities including but not limited to vendor qualification program, annual product reviews, internal audits, metrics collection across the company, and preparing for monthly quality council/management review meetings.

 

 

EDUCATION, SKILLS AND/OR EXPERIENCE

Responsibilities

Primary Responsibilities

  • Primary administrator for computer systems used in QC, such as Empower and stand alone instruments
  • Primary administrator for MasterControl company wide document/training/event management software
  • Support Manager Computer Systems Validation in generating/executing computer systems validation documents
  • Prepare change control documentation related to troubleshooting and preventive maintenance activities related to system administration responsibilities
  • Review existing computerized systems for compliance to company procedures, computer validation requirements, data integrity and 21 CFR Part 11 compliance as assigned
  • Write/Review/Update SOP’s related to computer systems in QC and MasterControl
  • Performs internal audits to ensure compliance against procedures and regulations

Support additional Compliance Department responsibilities as time allows:

  • Collects metrics across the company for trending of quality performance
  • Performs annual and quarterly trend reports
  • Authors and reviews Annual Product reviews
  • Performs external audits for suppliers and service providers
  • Manages the vendor qualification program
  • Provides support for execution of special quality projects to implement quality systems improvements to meet regulatory requirements
  • Provides support during FDA and other regulatory body inspections
  • Updates Standard Operating Procedures (SOP)

Supports other department as directed which may include:

  • Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis

Qualifications

  • Bachelors degree in life science such as Chemistry, Microbiology or related scientific field
  • 2-4 years Quality experience in the pharmaceutical industry
  • Experience with Computer System Validation following GAMP desired
  • Some knowledge of cGMP and FDA regulations
  • Proficient in the use of Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages
  • Experience with TrackWise, MasterControl or similar Quality Event Management software 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

Prepares proposals by determining concept; gathering and formatting information, writing drafts, obtaining approvals.

Responsibilities

  • Determines proposal concept by identifying and clarifying opportunities and needs; studying requests for proposal (RFP’s)
  • Meets proposal deadline by establishing priorities and target dates for information gathering, writing, review, and approval; entering and monitoring tracking data; coordinating requirements with contributors; contributing proposal status information to review meetings; transmitting proposals
  • Gathers proposal information by identifying sources; coordinating submissions and collections; identifying and communicating risks associated with proposals
  • Develops proposal by assembling information including product nature, objectives/outcomes/deliverables, implementation, methods, timetable, staffing, budget, standards of performance, and evaluation; writing, revising, and editing drafts including executive summaries, conclusions, and organization credentials
  • Prepares presentation by evaluating text, graphics, and binding; coordinating printing
  • Maintains quality results by using templates; following proposal writing standards including readability, consistency, and tone; maintaining proposal support databases
  • Obtains approvals by reviewing proposal with key providers and subject matter experts
  • Improves proposal writing results by evaluating and redesigning processes, approach, coordination, and boilerplate; implementing changes
  • Accomplishes organization goals by accepting ownership for accomplishing new and different requests, exploring opportunities to add value to job accomplishments

Qualifications

  • Minimum bachelor’s degree in chemistry or similar life science
  • Prior pharmaceutical experience
  • Strong written and verbal communication skills
  • Detail oriented
  • Strong problem solving skills
  • Technical documentation and layout skills
  • Process improvement focus
  • Strong coordination skills

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.