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

To ensure that all, new and existing laboratory equipment in all Frontida Biopharm Laboratories remains qualified and calibrated and in good working order by managing a team of metrology / calibration / instrumentation analysts. In addition, will manage the calibration of instruments in Manufacturing. This position will look for opportunities to improve existing service levels and determine opportunities for harmonization, quality improvement, and cost reduction.

Responsibilities

• Manage instrumentation master listing to support ARD, QC, and Manufacturing.

• Verify that the calibration schedule is maintained

• Arrange for service and report instruments

• Approve protocols and reports for qualifications and calibrations

• Write, approve and train on instrument related SOPS

• Supervise resident metrologists and instrumentation specialists, resolve priority conflicts, and assign tasks

• Perform additional projects at the request of QC/CMS/ARD Management. Freely communicate with the management staff from each functional area to understand changing priorities and ensure minimum to no service interruptions.

• Interact and coordinate services with the IT department as needed.

• Management of the Computerized Maintenance Management System (CMMS) which is Blue Mountain Regulatory Asset Manager.

• Purchase and qualify new instruments

• Must participate and successfully complete all training as required by the company.

• Other duties may be assigned.

Qualifications

Bachelor’s degree in Chemistry or related field of study and 5 years of experience in instrumentation or installing, calibrating, maintaining, and repairing equipment (i.e. HPLC, GC, UV/VIS, FTIR, and Spectrophotomete)r and 3 years supervisory experience or equivalent combination of education, training and experiences.  Pharmaceutical industry experience preferred.  Must have good written and oral communication skills.  Proficient in Microsoft Office applications (Word, Excel, Outlook) and business related application packages highly desired, plus the ability to learn company used applications.  Must have experience with Blue Mountain Asset Management software or similar product.

Knowledge and Skills

Supervisory 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.

 

 

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

This position works independently to conduct technical service, product and process development and optimization studies of pharmaceutical products such as immediate release or extended release solid oral dosage forms.  Has overall responsibility for the relaunch and  technology transfer of a product from pilot to commercial manufacturing in conformance with regulatory requirements (FDA, cGMP, DEA, etc.), and is responsible for designing, conducting and coordinating scientific studies for the physical/chemical characterization and pharmaceutical development.

Responsibilities

  •  Responsible for designing, conducting and coordinating scientific studies for physical/chemical characterization and pharmaceutical development.
  • Perform relaunch and scale up development and optimization of manufacturing process based on regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10).
  • Collaborate with R&D formulator and technicians regarding the design and execution of pilot and commercial process parameters, creation of formulation spread sheets, master batch record writing, batch execution, and post batch evaluation and analysis.
  • Executes experiments at lab scale and commercial scale to implement the use of quality by design (QbD) principles and design of experiments (DOE) to develop robust process parameters. Design the experiments using statistical software.
  • Evaluate retrospective quality by design (QbD) assessments of currently marketed products to improve quality, efficiency and mitigate potential cGMP and quality risk.
  • Review batch records, incident investigation reports, change controls, market complains, annual product review, product development protocols and reports, drug master files, validation documents, equipment qualification reports, technology transfer dossiers, stability data, raw material data trend, CAPAs, in process and finished product analytical data for understanding the process knowledge and identify the risks to the quality of the product.
  • Communicates to management an overview of products under development, and their stage of development.
  • Ensures compliance with all aspects of cGMP’s.
  • Assist Engineering staff for facilities design and equipment qualifications.
  • Assist Operations, Quality and Regulatory Affairs units as necessary.
  • Support R&D formulation development, Process Engineering, QbD, Scale up, Technical Service, Cleaning Validation, Process Validation, and Stability activities as mandated by cGMP’s policies/procedures and quality standards.
  • Review, as necessary, all pertinent NDA / ANDA documentation, cleaning procedures, batch history, and technical transfer reports prior to validation and/or scale up activities.
  • Prepare, approve & execute all necessary documentation, reports, protocols, batch records, etc. as required.
  • Perform process improvement projects and troubleshoot production processes.
  • Review SOPs and performance goals to ensure they reflect a commitment to quality and efficiency.
  • Perform other duties as assigned.

Qualifications

  • Bachelor’s Degree in a Science field, Pharmacy, Pharmaceutical Sciences, Chemical Engineering or related disciplines, with a minimum of 6+ years related experience and/or equivalent combination of education and experience in Pharmaceutical Development/Validation/ Manufacturing.
  • Good understanding of pharmaceutical unit operations such as blending, milling, compression, tablet coating and fluid bed coating process.
  • Experience with development of immediate and modified release technologies including matrix and pellet formulations is required.
  • Working knowledge of manufacturing equipment and/or minimal formulation knowledge is required.
  • Excellent oral and written communication skills required.
  • To perform this job successfully, an individual must be proficient in each essential duty and the ability to work with minimum supervision.
  • Thorough knowledge of regulatory filing requirements and the impact of guidance’s in streamlining the technical/ process operations is essential.
  • 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

  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical / process 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.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

Computer Skills:

  • Ability to use PC based software programs (e.g. Microsoft® Word & Excel) and statistical programs (e.g. JMP®, MiniTab®, etc) is a plus.
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)

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.
  • While performing the duties of this job, the employee is frequently required to stand, talk and hear.
  • The employee is required to walk, climb ladders and scaffolding, sit, use hands to finger, handle, manipulate small objects, and to feel, to reach with hands and arms, to climb or balance, to stoop, kneel, crouch, or crawl, to enter confined spaces through openings, and to taste.
  • The employee must regularly lift and /or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, the ability to determine visual density, and the ability to adjust focus.
  • The employee must be able to smell and to discern differences in odors.

Work Environment:

  • While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts.
  • The employee is occasionally exposed to wet and/or humid conditions, odors, vibrations, low light, high light, high places (on the roof, scaffolding, or ladders), confined spaces, and outside weather conditions.
  • 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

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

The Sr. Manager/Auditor, Compliance and Quality Systems will have the responsibility for managing and leading functions that include but are not limited to investigations, training, internal auditing, quality oversight of validation (process and computer), metrics and quality council primarily for Frontida PA and for Frontida Aurora where processes are shared across sites.

 

Responsibilities

  • Responsible for leading the compliance processes and quality systems including investigations, training, internal auditing, quality oversight of validation (process and computer), and metrics reporting.  Ensure these processes are designed and executed according to cGMP, company SOPs and applicable regulations.
  • Collect metrics across the company for trending of quality performance, identification of trends and improvement opportunities
  • Lead the quality council management review meetings by presenting metrics, quality initiatives and driving quality improvement across the organization
  • Manage direct reports and team, drive a high performing organization, develop personnel for current and future roles within Frontida
  • Provide Quality support for electronic system integration
  • Collaborate across sites to develop common processes and procedures where applicable
  • Drive continuous improvement of quality systems to proactively mitigate current and future risks to support business needs

Qualifications

  • Bachelor’s degree in in a related discipline with 10-15 years of experience in pharmaceutical quality with broad knowledge of GMPs, solid and oral dosage forms, manufacturing and auditing, required
  • Experience leading teams to improved performance demonstrated through metrics
  • Knowledgeable of cGMPs and regulations pertaining to quality system requirements for oral dosage forms, preferred
  • Experience with quality systems, investigation writing, CAPA, preferred
  • Experienced in conducting internal audits, and preparing for and hosting agency inspections and audits, preferred.

Knowledge and 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 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

Provide support in various functions to the QC and ARD Lab as Stability Coordinator.

Has knowledge of commonly used concepts, practices, and procedures used within a laboratory. Relies on instructions and pre-established guidelines to perform the functions of the job.

Responsibilities

  • Maintain stability database (QC and AR&D) and Log books (QC and ARD)/
  • Maintains stability Chambers.
  • Provide summary reports to R.A. and Q.A. for submission.
  • Prepare and issue analytical reports for pulled samples (QC).
  • Coordination of stability sample pulls and storage with various departments (QC,QA, ARD,R&D and R.A).
  • Dispose of released stability samples/DEA samples.
  • End of Year DEA stability sample destruction.
  • Provide schedule to different departments (QC and ARD).
  • Maintain control drug books and inventory ( QC and ARD).
  • Send data offsite for storage.
  • Maintain and reject stability data.
  • Write and review SOPs.
  • Maintain analyst training records.
  • Must participate and successfully complete all training as required by the company.
  • Perform other duties as assigned.

Qualifications

  • Bachelors  degree with 1 years of experience in the pharmaceutical or similarly regulated industry or equivalent combination of education and experience.
  • Strong communication and organizational skills.
  • Ability to maintain confidential information.
  • Intermediate level of proficiency in Stability database systems highly desired.
  • Proficient in the use Microsoft Office applications (Word, Excel, Outlook, Access) and business related application packages.
  • Experience with AS400, Master Control or similar software preferred. The ability to learn company used software applications.
  • Physical Demand: While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms and talk or hear. The employee must regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

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.