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 Biologics Drug Substance Process on a client site in Philadelphia, PA with the client's Biologics Development team.

You will support the development of recombinant therapeutic proteins and antibodies from Pre-clinical through BLA filing by serving as a Subject Matter Expert (SME) on upstream and / or downstream drug substance processes.

You will identify Critical Quality Attributes (CQA) and develop in-process control strategies. Management of CROs and CMOs will be a critical aspect of the position as all development and manufacturing activities are outsourced.

The position requires excellent technical writing skills and will author and review regulatory filings.

Responsibilities :

  • Provide subject matter expertise (SME) for upstream and / or downstream processes producing recombinant proteins and antibodies
  • Author and review CMC modules of IND and BLA filings
  • Support tech transfer of biologics drug substance processes to commercial scale contract manufacturing organizations (CMOs)
  • Serve as Person in Plant (PiP) during production campaigns to act as liaison between manufacturing facility and drug substance team
  • Design and implement strategies for drug substance process improvements and characterization at CMOs
  • Collaboration with cross-functional teams to drive and deliver on multiple projects
  • Domestic and International travel for up to 10 days supporting manufacturing campaigns, project meetings and development operations
  • Keeps abreast of industry best practices and technological advancements in biologics manufacturing and utilizes those to further enhance department’s capabilities.
  • Completes all EHS related training and ensures Client development and commercial production operate safely and adhere to all regulatory requirements
  • 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 :

  • 10 years of hands-on development experience
  • In-depth understanding and hands-on experience in upstream production of recombinant proteins and MAbs. Prefer experience with both microbial and mammalian systems.
  • In-depth understanding and hands-on experience in process purification techniques including chromatography (AKTA), TFF, depth filtration and formulation
  • Working knowledge of molecular biology practices
  • Skilled at technical writing and prior experience authoring and reviewing IND and BLA filings
  • Demonstrated experience in tech transfer of a process from development to manufacturing or between manufacturing sites.
  • Understanding of Phase appropriate regulatory requirements for Biologics Drug Substances processes
  • 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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