Program/Project Manager
Pharmaceutical Product Development, LLC
PA
hace 33 días

EXPECT MORE FROM YOUR CAREER

EXPECT PPD

PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.

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

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

time benefits / advantages of being a part of PPD.

As a Program / Project manager in this role you will be part of a Biologics Product Development team. You will provide scientific and administrative direction for the development and validation of bioanalytical methodology to support manufacture and development.

This position has accountability for technical decision-making. You will be a major contributor to the writing of technical development reports as well as regulatory submissions and will work with external CMOs / CROs as well as the client Quality and Regulatory organizations to ensure that their products meet the highest standards for quality and supply.

Responsiblities

  • Manage contract method development. Oversee work flow, progress, and milestone achievements
  • Responsible for all aspects of technology transfer of analytical methods to the designated manufacturing group.
  • Ensure methods being developed represent commercially practical quality and process controls.
  • Define appropriate analytical methodology for quality and regulatory controls for Drug Substance, Drug Product, and critical intermediates.
  • Oversee method scouting, qualification and validation in accordance with appropriate regulatory requirements (FDA at a minimum, EMA a plus)
  • Design and manage appropriate stress and stability studies, and organize analysis and reporting of data
  • Ensure practices and procedures in GXP assays data analysis are GXP compliant.
  • Prepare, review, and revise SOP and test methods.
  • Write / review method development reports
  • 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 and working in cross-functional work teams.
  • Education and Experience

  • B.S. / B.A. in Chemistry, or related field with 4 years lab related experience in the pharmaceutical and / or biotech industries or
  • M.S. in Chemistry, or related field with 3 years lab related experience in the pharmaceutical and / or biotech industries
  • Ph.D. in Chemistry, or related field with 2 years lab related experience in the pharmaceutical and / or biotech industries
  • Including 1-2 years experience working with single or multiple lab studies to include the areas of stability, QC, and method development and validation
  • In some cases a combination of education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job accountabilities satisfactorily.
  • Knowledge, Skills and Abilities

  • Knowledge and proficiency in analytical chemistry technologies associated with cGMP studies.
  • Experience managing contract analytical development for biologics
  • Experience in characterization of a variety of biologics by orthogonal methodologies as well as standard QC methodologies for different dosage forms (lyo, liquid, tablets, etc)
  • Experience in managing method development from Phase 1 to post-approval
  • Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills.
  • Excellent problem solving, judgment and decision-making skills.
  • Demonstrated proficiency in troubleshooting and problem solving and use of experimental design to elucidate effects of variables.
  • Effective oral and written communication skills.
  • Proven organizational and negotiation skills.
  • Understanding of basic budgeting and forecasting terms and definitions
  • Full understanding of cGMP requirements, ICH guidelines, USP requirements and FDA guidance
  • Ability to multi-task and effectively prioritize workload
  • Detail oriented
  • Excellent computer skills
  • Possesses good interpersonal skills and positive attitude.
  • 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
  • Inscribirse
    Añadir a los favoritos
    Elimnar de mis favoritos
    Inscribirse
    Mi Correo Electrónico
    Al hacer clic en la opción "Continuar", acepto que neuvoo recolecte y procese mis datos de conformidad con lo establecido en su Política de privacidad . Tengo derecho a darme de baja o retirar mi autorización en cualquier momento.
    Continuar
    Formulario de postulación