***This position requires long term eligibility to work in the US without sponsorship. Please note F-1 OPT Visas are not considered long term eligibility for this role.
In labs and health care facilities worldwide – HERE WE ARE
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.
An Associate Scientist / Scientist on this analytical team plays a supporting role for biopharmaceutical products’ lifecycle activities. The team focuses on support for commercialized and late stage products with a focus on establishing the analytical CMC strategy; enabling regulatory filings, providing technical partnership for quality control laboratories around the world, managing the life cycle of specifications (methods and acceptance criteria), and authoring/reviewing responses to health authority questions on commercial products.
This role is 100% desk /office based (non-lab).
The Associate Scientist / Scientist will collaborate with different sites for analytical development, global quality product leads, technical project teams, and regulatory leads to generate and execute the pre- and commercial strategies for drug substance and drug product methods and specifications, network analytical control strategies, and support of life cycle regulatory filings. Through strong leadership, the Associate Scientist / Scientist will ensure the support of analytical methods and analytical change control across the network, for third party manufacturing and our partners at outside testing labs. The Associate Scientist / Scientist is responsible for data gathering, interpretation and presentation to support decision making and product analytical strategies.
- Create and maintain effective partnerships with stakeholders from analytical development, manufacturing sciences and technology, Supply Chain, Regulatory, Quality, Process Sciences, Drug Product Development, Project Management, and Manufacturing to deliver analytical strategies with a high probability of technical and regulatory success, as necessary.
- Manage and coordinate analytical activities for late-stage and commercial programs.
- Effectively supports team matrix for analytical topics during all BLAs, ROW & PAS filing review and works with analytical development in supporting the responses to FUMs and PMCs.
- Participates on the implementation of effective control strategy, analytical method and specification change control as needed throughout the network, third party manufacturing and outside testing labs.
- Serves as subject matter expert for project for activities, including technical evaluations of methods and data.
Education and Experience:
- Bachelor’s degree in a scientific field (Biology, Biochemistry, Chemistry, etc.) or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2+ years).
Knowledge, Skills and Abilities:
- Proven ability in technical writing skills
- Knowledge in analytical methodologies used for the development and commercialization of biologics.
- Demonstrates a broad expertise and experiences in analytics routinely used for in-process, release and stability testing of Biologics or Protein Therapeutics drug substance and drug product.
- Working knowledge of biologics CMC regulations and cGMP requirements, as well as experience in supporting regulatory filings.
- Demonstrated skills working in cross-functional strategic teams and collaboration with internal and external partners.
- Strong decision-making skills
- Proficient in Microsoft Excel and Word
- Proven problem solving and troubleshooting abilities
- Strong written and oral communication skills and leadership skills in a highly interactive environment
- Time management and project management skills
- Ability to work in a collaborative work environment with a team
PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
PPD Defining Principles:
We have a strong will to win – We earn our customer’s trust – We are gamechangers – We do the right thing - We are one PPD -
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.