Principal Program / Project Manager
Pharmaceutical Product Development, LLC
PA
hace 32 días

EXPECT MORE FROM YOUR CAREER

EXPECT PPD

PPD is a leading global contract research organization. At PPD weare passionate, deliberate, and driven by our purpose - to improvehealth.

PPD Laboratories offers the most comprehensive set of laboratoryservices available in the industry and continues to deliver innovativesolutions to our clients through our collaborative approach, including PPD®Laboratories FSP.

PPD® Laboratories FSP is a unique partnership that allows ourclients to leverage the experience of our PPD staff, while allowing you, theemployee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-

time benefits / advantagesof being a part of PPD.

Job Summary

In this role you will be working with Formulation & Fill Finish Process Development. You will provide scientific evaluation and direction for the development and validation of patient convenient formulations and robust aseptic fill finish processes for liquid and lyophilized biologics.

This position requires solid understanding of aseptic processing principles as applied to parenteral sterile liquid and lyophilized drug product manufacturing, hands-

on experience with the use of multivariate process analytics and statistical or other experimental design techniques (MVA, DOE, QbD) to drive complex, technical workflows to ensure successful process unit operations integration with the product formulation and delivery device requirements.

In depth knowledge of scale down models and design of edge of failure experiments simulating compounding, mixing, sterile filtration and filling operations for both liquid and lyophilized dosage forms is required.

Experience in manufacturing high concentration, viscous biologics is a plus. Additional requirements include solid experience characterizing process and container closure parameters ranges, critical for fill finish operations of combination products, demonstrated record successfully developing and outsourcing fill finish processes from early stage to commercialization including life cycle management, experience in supporting validation campaigns, etc.

This position has accountability for technical decision-making and will be a major contributor to the writing of technical development reports as well as global regulatory submissions.

You will be responsible for Drug Products manufacturing for clinical campaigns according CMC project development plan, timeline and resources.

This role will work with the Clinical, Quality, Regulatory, and Supply Chain organizations to ensure that our client's products meet the highest quality and supply standards.

Responsibilities :

  • Provide technical leadership of formulation and drug product process development and validation for liquid and lyophilized biologics.
  • Oversee external CMO, work flow, progress, and milestone achievements.

  • Responsible for formulation and fill finish process development and validation, knowledge management according QMS requirements, regulatory filings and drug products launch support for biologics.
  • Conduct risk assessment for drug product operations to support fill finish process development, scale up, technical transfer, and clinical manufacture.
  • Spearhead operational excellence and process improvement initiatives to improve product quality, reliability and reduce risk.
  • Lead process modeling, data trending and advanced statistical & process analysis.
  • Design and manage appropriate development, stability and stressed studies, and organize analysis and reporting of data
  • Comply with applicable GMP, regulatory, ISO and other professional requirements for parenteral drug products during development, validation and commercialization.
  • Responsible for CMC support of regulatory filings for formulation and aseptic fill finish process
  • At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-

    winning training programs speak for themselves.

    Join PPD in our relentless pursuit of excellence - apply now!

    Qualifications

    Education and Experience :

  • Bachelor's degree in Chemical Engineering, Biopharmaceuticals, Biochemistry or equivalent with at least a Master’s degree preferred and relevant formal academic / vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience.
  • Knowledge, Skills and Abilities :

  • Experience in directing formulation and drug product process development from preclinical to post-approval.
  • Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills with ability to multi-task
  • Proficiency managing contract product manufacturing for biologics as well as drug product fill finish process scale up and technology transfer.
  • Demonstrated proficiency in troubleshooting and problem solving and use of experimental design to elucidate effects of variables.
  • Experience with computational fluid dynamics is desirable.

  • Excellent written and verbal communication skills.
  • Ability to collaborate with Global Manufacturing, Supply, Quality, Regulatory and other functions to ensure manufacturing processes are commercially viable and meet highest quality and supply standards.
  • Design and manage appropriate stress and stability studies. Organize analysis and reporting of data
  • Provide support to project teams and participate in strategies for product development and obtaining regulatory approval.
  • This position requires proven abilities and skills in leadership, project management and working in cross-functional work teams.
  • At least 7 years of hands-on experience in aseptic drug product fill finish and formulation development and validation for biologics preferably in pharmaceutical or biotech company.
  • Experience in outsourcing and project management is strongly preferred.

  • Previous formulation and fill finish process project management experience from early feasibility to commercialization. Is strongly desired.
  • Deep understanding of global regulatory guidance documents for parenteral sterile liquid and lyophilized drug product manufacturing is required.
  • Strong technical writing and oral communication skills are required. Experience preparing information for IND, BLA, PMA, etc. submissions is a plus.
  • Able to solve complex and diverse scientific and technical problems through original thinking and deductive reasoning.
  • Proficiency in manipulation, analysis and trending of data in Excel and statistical programs.
  • Excellent communication, negotiating, and computer skills.
  • Strong team orientation.
  • Excellent problem solving, judgment and decision-making skills
  • Strong verbal, written and presentation skills
  • Proven organizational and negotiation skills
  • Extensive knowledge and proven leadership in project management
  • Understanding of basic budgeting and forecasting terms and definitions
  • Superior time management, planning, and organizational skills
  • Full understanding of laboratory requirements, ICH guidelines, USP requirements and FDA guidance
  • Ability to multitask and effectively prioritize workload
  • Ability to work effectively with multi-level teams
  • Ability to work in a fast-paced undefined environment
  • Strong client relationship management skills
  • Working Conditions and Environment :

  • Work is performed in a laboratory and / or a clinical environment with exposure to electrical office equipment.
  • Occasional drives to site locations, occasional domestic travel.
  • Exposure to biological fluids with potential exposure to infectious organisms.
  • Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
  • Personal protective equipment required such as protective eyewear, garments and gloves.
  • Exposure to fluctuating and / or extreme temperatures on rare occasions.
  • Physical Requirements :

  • Ability to work in an upright and / or stationary position for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
  • Occasional mobility needed.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.
  • Requires multiple periods of intense concentration.

  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
  • Ability to perform under stress. Ability to multi-task.

  • Regular and consistent attendance.
  • PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.

    Primary Location

  • North America-United States-Pennsylvania-FSP2 Philadelphia, PA
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