What are the responsibilities and job description for the Materials and Components Scientist position at Pfizer?
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
The incumbent works as part of a team to perform scientific tasks as they relate to technology transfer, scale-up operations, capital projects, and routine manufacturing support. The incumbent should have the cross-functional scientific skills and knowledge of fermentation/recovery, purification and conjugation chemistry. The incumbent is expected to have the scientific acumen to quickly adapt to cross-functional training as needed to advance pipeline projects.
The incumbent will serve as the technical lead responsible for supporting the enrollment of new chemical and non-chemical materials and perform assessments of supplier changes to existing chemical and non-chemical materials intended for clinical/commercial manufacturing. The incumbent must also be able to maintain GMP documentation and comply with applicable safety, occupational health, loss prevention and environmental requirements.
How You Achieve It
Support product transfer, production, and capital projects in a technical capacity. As vaccine and gene therapy candidates progress through the research pipeline from development through Phase III clinical production, the incumbent will work with internal and external development colleagues to understand the material enrollment and supplier change notification review needs. This includes the following which may be performed in collaboration with or guidance from senior level colleagues:
1. Manage competing enrollment tasks supporting vaccines and gene therapy programs. Show flexibility in supporting with potential shift in deadlines.
2. Maintain excellent communication skills with stakeholders (program managers, fellow enrollment team members, and other site colleagues). Lead collaborative and cross-functional meetings and conversations to address material concerns and establish resolutions by targeted project timelines.
3. Perform technical assessments of chemical raw materials and non-chemical components used in the Sanford manufacturing processes. Understand the potential process impact from material (i.e. raw material specification change, new additive added to supplier component manufacturing operation, required path forward necessary to assess quality and use material beyond expiry). Familiarity with leachable/extractable data and method of evaluation a plus.
4. Perform risk assessments of materials and their potential quality impact as needed. Familiarity with quality risk assessment and management tools (FMEA, statistical tools, etc.) a plus.
5. Support/author change controls relating to material changes to GMP-related activities, processes, and systems. Familiarity with the electronic quality tracking system a plus.
6. Create, edit and maintain SOPs needed for new processes within the approved QA document management system. Lead the revision process of documents as they evolve and track approval of new and revised documents through the QA document approval process.
7. Maintain careful and accurate records of material enrollment and supplier change notice tasks. Utilize data and findings to contribute to meetings and make presentations on specific material issues. Provide observations/comments during schedule planning and process development meetings.
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to manufacturing. Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities. Review company and site-specific SOPs, policies, and procedures and develop processes that meet the quality requirements set forth in these documents.
QUALIFICATIONS
A minimum of a BS degree in either of the following discipline: chemistry, biochemistry, biotechnology, chemical engineering or equivalent science related field or engineering discipline.
4 to 7 years of experience; or equivalent combination of education and experience is required for this position.
Knowledge of the manufacturing process and equipment, preferably fermentation, purification and protein conjugation processes. Unit operations that include fermentation, centrifugation, hollow fiber filtration, depth filtration, UF diafiltration/concentration, column chromatography, and dispensing operations
PHYSICAL/MENTAL REQUIREMENTS
Job functions require working in an office setting where sitting and computer usage would be the norm. Onsite and remote working may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Schedule is primarily day shift, but at times it will be necessary to work additional times to support material enrollment and change notification activities within their deadlines.
OTHER INFORMATION
Last Date to Apply: April 18th , 2022
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
