Manufacturing Lead

Employer
Proclinical Staffing
Location
Pennsylvania, USA, Philadelphia
Salary
Highly Competitive Salary
Start date
24 Jan 2023
Closing date
7 Feb 2023
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Job Details

Proclinical is seeking a Manufacturing Lead for a leading biopharmaceutical company located in Philadelphia, PA.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

  • Develop a comprehensive understanding of and be able to proficiently execute company's current cell therapy manufacturing process, as this role is viewed as a subject matter expert within specific area.
  • Support management with the alignment of manufacturing processes with technical training and ensure consistent alignment between the processes. Supports technical transfer and additional research level testing activities.
  • Deliver training sessions and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
  • Provides operational support functions including materials stocking, kit preparation, reagent preparation, cleaning activities, and equipment maintenance.
  • Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of processing.
  • Understands and complies with quality standards and requirements as documented. 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.
  • Support documentation needs, which may including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Contribute to department operations improvement in areas such as document revisions and department inspections.
  • Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review documentation of functions performed as part of quality control requirements. Review data as generated/collected by less experienced technical staff.
  • 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.
  • Attends the daily lab meeting and escalates issues/concerns at that forum to Area Management for further investigation.
  • May work on assignments that are moderately complex in nature, where judgment is required to troubleshoot and resolve operational issues without negatively impacting manufacturing efforts.
  • Other duties as assigned.

Skills and Requirements:

  • Minimum bachelor's degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Minimum of 4 years of experience in biopharmaceutical based GMP manufacturing operations, including experience in cell culture and associated downstream processing. Cell therapy experience preferred.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must.

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at (+1) 267-297-3280 or b.copeland@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.

#LI-BC1

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Find Us
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
GB

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