Sr. Associate Scientist, QC Chemistry

Pfizer • Sanford, NC

1d • Onsite

About The Position

You’ve just received life changing news…cancer! The doctor recommends several rounds of chemotherapy. Unfortunately, chemotherapy not only targets the cancerous cells but the healthy tissues as well. During chemotherapy treatments, you experience fatigue, immunosuppression to other diseases, nausea/vomiting, hair loss, and other symptoms. What if there was a way to deliver that cytotoxic drug directly to the cancerous cells and not indiscriminately to healthy cells across the body, significantly reducing the adverse effects observed with chemotherapy? Pfizer is at the forefront of antibody-drug conjugates (ADCs) biotherapeutic development. ADCs attach a cytotoxic drug (monomethyl auristatin E or MMAE) directly to an antibody which is released upon uptake into the tumor-expressing cell killing it. This novel technology significantly minimizes the impact to healthy cells, thus reducing the toxic effects observed in chemotherapy and being a far more effective way to treat patients and increase survivability to life altering diagnosis. Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What You Will Achieve In this role, you will: The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, and validation.  Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing, analyzing, interpreting, and trending results; and creating, reviewing and approving documentation. Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs. At a minimum, the individual should be considered able to demonstrate the following: Acts safely and follows all EH&S safety requirements for site and QC laboratories. Be recognized as a “go-to” person or Subject Matter Expert for a specific subject area and are considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and compliance to regulations and Pfizer policy and standards. Excellent written and verbal communication skills Ability to identify issues, present complex problems with possible solutions , and actively take a leadership role to resolve issues. Ability to solve highly complex mathematical problems and situation-dependent problems using convoluted information. Ability to receive feedback from management and colleagues and take accountability for actions and personal development. Aptitude for good decision making based on procedures, guidance, and experience. Awareness to know their own limitations and seek senior scientist or management guidance when appropriate . Desire to ensure correctness and accuracy in tasks and documentation. Fitness of functioning as a team member and performing independent work with minor guidance Willingness to use personal skills and knowledge to achieve individual and company goals and objectives . Understanding of own area of function and knowledge of other cross functional areas Able to create,review, and approve test method and/or equipment validation records with limited guidance/coaching. Understands the importance of feedback and receives feedback well from management and other colleagues. Makes good decisions based on knowledge of quality systems and technical experience. Recognizes the impact of procedural changes that may impact future quality tasks and decisions. Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations. Responsible for personal timelines and seeks advice if conflicts arise. Interacts with business lines and shares information with team; capable of influencing and negotiating with business lines. Ability to communicate effectively with good interpersonal skills. Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories. Support routine testing and analysis of batch samples associated with vary modalities in a QC setting . Follow Environment Health and Safety requirements for site and QC laboratories. Perform complex mathematical problems and data analysis. Support product transfers, new product development, regulatory queries, cost improvement projects, and Drug Product plant support for Cleaning Validation. Operate within established HR policies and basic colleague relations guidelines. Write Standard Operating Procedures (SOPs), technical reports, project plans, etc.

Requirements

• Applicant must have a Bachelor's degree with 0+ years of experience; OR an Associate's degree with 4 years of experience; OR a High School diploma (or equivalent) and 6 years of relevant experience.
• Demonstrated knowledge of manufacturing, quality or engineering practices in the biotech or pharmaceutical industry
• Perform analytical separation determination of antibodies and/or bio-conjugates utilizing advanced separation techniques (e.g. SEC-UPLC, RP-UPLC, HILIC-UPLC, IEX-UPLC, CE-SDS, iCIEF, etc.) within cGMP compliance in support of pre-clinical and commercialization
• Aptitude for good decision making based on procedures, guidance, and experience.
• Effective communication skills
• Knowledge of Microsoft Office applications, specifically Word and Excel
• Excellent effective written and verbal communication and interpersonal skills
• Ability to work in a team environment.

Nice To Haves

• Relevant experience in biotherapeutics (antibodies, vaccines, and gene therapy)
• Experience with Laboratory Information Management System (LIMS)

Responsibilities

• Perform tasks associated with maintaining Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories.
• Support routine testing and analysis of batch samples associated with vary modalities in a QC setting .
• Follow Environment Health and Safety requirements for site and QC laboratories.
• Perform complex mathematical problems and data analysis.
• Support product transfers, new product development, regulatory queries, cost improvement projects, and Drug Product plant support for Cleaning Validation.
• Operate within established HR policies and basic colleague relations guidelines.
• Write Standard Operating Procedures (SOPs), technical reports, project plans, etc.

Benefits

• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level