Job title: Manufacturing Specialist
- Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
- Lead (act as project manager for) teams investigating major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
- Own and manage change controls associated with manufacturing areas and equipment. Participate in technology transfer, conference calls and sharing of technical information.
- Trending of monthly manufacturing metrics and “Health of the Operations”
- Coordination of front-end document requests with supporting departments
- Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records are reviewed and approved in a timely manner.
- Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of document review and revision.
- 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.
- Attends the weekly management meeting to discuss timelines and weekly priorities
- Manage projects to ensure timely initiation and completion of work.
- May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
- Troubleshoot issues and prioritize workload to solve moderately complex problems.
- 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.
- Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
- 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 1 – 3 years of experience in biopharmaceutical based GMP manufacturing operations.
- 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.
- 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 representing a variety of personalities and experience levels.
- 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.
- Understands and complies with quality standards and requirements as documented.
- Must have strong written and verbal communication and organizational skills.
- Strong computer skills, problem solving and attention to detail.
- Familiarity with data and sample management required (LIMS/MES)
- Able to work independently with minimal supervision.
- Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
- This position is currently for regular work week hours (1st shift M-F)
- Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
- May require up to 10% travel, based on business need.
- Must be able to work in environment with variable noise levels
- Must be able to work in Cleanroom setting with Biohazards /various Chemicals
- Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Potential exposure to latex, bleach, noise, equipment hazards, and strong odors in production environment
If you are having difficulty in applying or if you have any questions, please contact Sam Jankura at (+1) 617-671-0335 or [email protected].
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.
Job date: Sun, 10 Jul 2022 04:39:37 GMT
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