- Development and revision of Master Batch Records, Work Instructions, Logbooks, Forms and Standard Operating Procedures to support manufacturing, tech transfer projects, internal CAPAs, deviations and continuous improvement objectives.
- Manage and track assigned documents through the entire life cycle (i.e. creation, review, revision, approval) using detailed project planning to meet project milestones.
- Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
- Support tech transfer of new products and processes to ensure smooth transition from process development/clients into GMP manufacturing.
- Serving as a scientific and technical representative for process-related issues at the facility.
- Partnering with Process Development and Operations to meet the production schedule, ensure product supply and uphold quality standards.
- Performing trending and monitoring of process parameters/critical quality attributes/critical process parameters to maintain product quality and to control process drift.
- Implementing process improvements in conjunction with operations.
- Participating in start-up efforts of new equipment, software or processes in manufacturing.
- Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes.
- Providing technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc.
- Assist in utilizing small-scale production processes and using scaled-down lab processes to enable process troubleshooting.
- Assist in implementing opportunities for operational excellence and continuous improvement.
- Partner with Quality to ensure a quality and compliant manufacturing environment.
- Assist the technical operations team to resolve any issues related to production.
- Participate in root cause analyses for deviations and assist in implementation of CAPA.
- Prepare and review documentation such as SOPs, batch records, and risk assessments for client process.
- Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field.
- Excellent oral and written communication skills.
- 1-5 years experience in viral vector/cell therapy (or biopharmaceutical) based GMP manufacturing operations including direct experience in cell culture, cell selection, recovery, purification, and/or aseptic fill/finish.
- Demonstrated technical writing capability.
- Familiar with global regulations on cGMP manufacturing of drug substance, drug product, and/or validation/qualification requirements
- Proven ability to participate within matrix teams while developing capability to lead smaller teams.
- Working knowledge of cGMPs related to the production of viral vector/cell therapies.
- Extremely high levels of flexibility, initiative, solution-orientation, and tenacity.
- Thoroughly understand the cell and gene therapy manufacturing processes along with associated equipment and technologies to support issue resolution for manufacturing operations.
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
- Standing in a manufacturing setting for more than four (4) hours, when required.
- Documentation writing and batch records.
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Downstream MSAT Associate Scientist/Engineer - King of Prussia, United States - SK pharmteco
Description
Position: Downstream MSAT Associate Scientist/Engineer
Location: (On-site) King of Prussia, PA
The Associate Scientist/Engineer in MSAT is responsible for assisting in the transfer and implementation of manufacturing processes used to manufacture client cell and gene therapy products at the Center for Breakthrough Medicines. This individual will work with internal and external organizations to author batch documentation (i.e. Master Batch Records), author SOPs/Work Instructions, assist with process fit to plant analysis, facilitate process risk assessments, and other activities required to support GMP operations stand-up. Additionally this role will assist in continuous improvement objectives such as process yield improvements, error reduction initiatives, and CAPA identification to support investigations. The Associate Scientist/Engineer will assist in the management of process and characterization knowledge related to the GMP production of advanced therapy products.
This role will be responsible for supporting the collection and interpretation of process data as well as collaboration with other departments on manufacturing related issues to drive resolution and process improvements. This position will involve hands-on troubleshooting of the manufacturing processes and assist in the authoring of technical reports. Other responsibilities include providing assistance in manufacturing led investigations through partnerships with Quality and other business units at the site. Work to determine root cause, implementation of solutions and a verification check to ensure the CAPA was effective. The Associate Scientist/Engineer may be responsible for owning a portion of the process, ensuring Right First Time manufacturing, planning ahead to avoid delays, good documentation practices, and participating in continuous improvement and operational excellence projects to help drive efficiency, while error
proofing the process.
Responsibilities:
Requirements:
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Physical Requirements:
GTS Scientific is a recruiting company specializing in executive, scientific and technical placements for the biopharmaceutical, medical device, engineering and chemical industries. Our quality driven recruiting process allows us to identify the ideal candidates for our clients, from mid-level employees to senior executives. We partner with our clients hiring managers to determine the required staff with the appropriate skill sets to achieve strategic company goals. Our recruiting experts identify and build personal relationships with the most qualified candidates in the marketplace today; these strong industry relationships allow us to react quickly to our client's requirement
