Manufacturing Operations Lead
Proclinical is currently recruiting for a Manufacturing Operations Lead with a pharmaceutical company located in Philadelphia, PA.
- Deliver training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
- Assists with identification of training needs, establishing a feedback loop to ensure continuous improvement, and using key performance indicators to measure training effectiveness.
- Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
- Understands and complies with quality standards and requirements as documented.
- Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
- Supports technical transfer and additional research level testing activities.
- Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
- Supports documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
- Attends the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
Skills and Requirements:
- Minimum B.S. degree in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
- Minimum of 6 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
- Demonstrated technical knowledge of aseptic processing in cleanroom environments is a must.
- Strong knowledge of and experience in in-lab skills training, including aseptic technique and cell culture processing.
- Experience leading "development" initiatives, i.e., training, coaching, learning initiatives.
- Ability to mentor and provide best practices to other members of the team.
- Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing environment (potentially 50+ employees) representing a variety of personalities and experience levels.
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
- Ability to deal with ambiguity - ready to change gears and plans quickly, with the need to manage constant change.
- Ability to work successfully in a fast-paced team-oriented environment.
- Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
- Excellent presentation skills, both written and verbal.
- Lead Technician is required to work the assigned schedule. This position is currently for regular work week hours (1st shift M-F); however, due to the nature of cell therapy manufacturing schedules, must be willing to work alternative shifts, weekends, evenings, and holidays, as needed. It is also expected that regular work weeks may change once commercial manufacturing commences and may involve shift changes (i.e. Tuesday to Saturday). May be required to work overtime.
- Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
- Works in production environment with exposure to latex and bleach. Potential exposure to noise and equipment hazards and strong odors.
- Ability to lift 20 lbs
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.
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.