Associate Scientist

Use Your Power for Purpose

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:

• Assist in the preparation and maintenance of media stocks, including sterilization of accessories by autoclave cycles.

• Manage receipt, storage, and handling of Bio ball cultures, and assist in the maintenance of Master cultures and preparation of Cryo vials.

• Perform various microbiological tests such as water analysis, Microbial Limit Test, Sterility tests, Bacterial Endotoxin Test, CCIT, and micro challenge studies.

• Ensure training records are updated and correctly filed to reflect current testing capabilities.

• Perform sampling and labeling of materials as per defined procedures and verify all equipment and instruments.

• Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.

• Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.

• Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.

• Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database, and generate EMS reports.

• Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.
  
  Here Is What You Need (Minimum 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

• 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

• Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis

• Demonstrated technical skills in method validation and testing

• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations

• Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.

• Excellent organizational skills and strong ability to multi-task

• Strong written and verbal communication skills

• Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
  
  Bonus Points If You Have (Preferred Requirements)

• Proven track record in leading continuous improvement projects

• Strong problem-solving sk