Cell & Gene Therapy Manufacturing Associate - Contract - Onsite
Proclinical Staffing is seeking a Cell & Gene Therapy Manufacturing Associate to join a cutting-edge biotech company. This is a contract role located in Philadelphia, PA.
Primary Responsibilities
The company's lead candidate is an autologous, ready-to-infuse cell therapy, that has demonstrated distinctive efficacy in the treatment of metastatic melanoma. The company has Phase 2 clinical trials in progress for squamous cell carcinoma of the head and neck, cervical carcinoma, non-small cell lung cancer, and immunotherapy for solid tumors. The company currently is developing its clinical and commercial manufacturing capacity to support development and launch of these assets.
As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualification, and ISO class 5 cleanroom operations is strongly desired.
Skills & Requirements:
- Bachelor's degree, or some post-secondary education.
- Must be able deal with ambiguity - ready to change gears and plans quickly, able to manage constant change.
- Must be able to read, write and understand English especially for Good Documentation Practices, and be proficient in Microsoft (Excel, Word, Outlook).
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- Ability to build relationships quickly and credibly.
- Ability to work successfully in a fast-paced team-oriented environment.
- Must adhere to core values, policies, procedures and business ethics.
- Minimum 0-1 years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Proactive, results oriented, self-starter with experience in a complex manufacturing environment.
- May require up to 5% travel, based on business need.
The Cell & Gene Therapy Manufacturing Associate will:
- Develop a comprehensive understanding of and be able to proficiently execute our GMP cell therapy manufacturing process(es).
- Complete training sessions and ensure training documentation is maintained.
- Understand and comply with quality standards and requirements as documented.
- Provide operational support functions including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Perform document review, including executed Batch Records and Logbooks.
- Aseptic Manufacturing Technicians are required to work their assigned schedule. The first few months of onboarding training for this position will occur during regular work week hours (1st shift M-F); however, once the technician is trained, they will be assigned to a shift that may include weekends, evenings, and holidays, as needed (i.e. Shifts may be Sunday to Wednesday, Wednesday to Saturday, Thursday to Sunday, etc). May be required to work overtime.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Attend the daily huddle meeting and escalates issues/concerns at that forum to Area Management for further investigation.
- Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Other duties as assigned.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at (+1) 267-428-7770 or m.raletz@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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