MS&T Engineer III

Cellipont Bioservices • The Woodlands, TX

4d

About The Position

Cellipont Bioservices are growing, and we are looking for a MS&T Engineer III who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. The MS&T Engineer III will support Manufacturing Operations in the successful transfer of clinical drug substance and drug product cGMP manufacturing operations. The MS&T Engineer III is actively engaged in the translation of client and Cellipont Process Development information for implementation of cGMP processes. The individual will serve as a subject matter expert (SME) for Autologous and Allogenic Cell Therapy Production. Success in this position requires the ability to learn processes/draft documents in a timely manner, work hands on in a cleanroom, and the ability to collaborate in a cross-functional, fast-paced environment. This role will also require the individual to demonstrate strong customer service capability, ability to work cross-functionally and possess strong leadership skills.

Requirements

• Bachelor's Degree in Biological Science preferably in: Biotechnology, Biochemistry, Bioengineering, or related technical field
• Minimum of 4+ years' experience in biopharmaceutical based GMP manufacturing with preferred 2+ years of direct experience in Autologous and/or Allogenic Cell Therapy and/or CDMO experience.
• Solid knowledge of FDA regulations and GMP systems
• Must be comfortable engaging, and communicating manufacturing related topics with external clients.
• Experience in writing, executing and reviewing SOPs / MBRs while maintaining proper GDP guidelines.
• Good mechanical aptitude, familiar with multiple equipment/technologies associated with Cell Therapy Processing.
• Extensive experience in aseptic manipulations in a Grade A (ISO 5) BSC.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Must be highly motivated, follow oral and written instructions, communicate effectively, think logically, and thrive independently and/or in a fast-paced team environment.
• Must be proficient in Microsoft Word and Excel. Experience in Microsoft Projects, Visio, and preferred.
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.
• Must be available to work occasional weekend or holiday support as needed

Responsibilities

• Support cell therapy technology transfer projects including coordination of process information exchange, documentation of process parameters, and tracking process performance.
• Work cross-functionally with Process Development/Analytical Development on new product introduction/sustaining products.
• Serve as technical subject matter expert (SME) on all assigned Autologous and Allogenic Cell Therapy programs.
• Provide technical support of cGMP manufacturing including authoring of technology transfer documents i.e., Master Batch Records (MBRs), SOPs, change control, and manufacturing investigations.
• Analyze manufacturing performance through data review and analyses. Author manufacturing summary reports. Establish and maintain data repositories.
• Lead cross-functional troubleshooting and operational improvements for manufacturing equipment.
• Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing.
• Support equipment validation (IQ/OQ/PQ)
• Produce material that meets the site's strategic objectives and is compliant with cGMPs and safety regulations.
• Technical collaboration on all process related deviations; assist in the departmental investigation, close out of deviations, as well as assist with the creation of robust CAPAs.
• Technical SME and POC to assist in troubleshooting process escalations
• Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions.
• Work closely with supply chain management for current and new manufacturing projects and help develop processes/techniques to meet client objectives and avoid operational delays.
• Serve as manufacturing liaison to external clients during routine meetings and/or audits.
• Adhere to all cGMP manufacturing operations, documentation, and safety guidelines.
• Respect environmental health and safety (EHS) rules in working area.
• Other duties as assigned.

Benefits

• Opportunities for career growth within an expanding team
• Defined career path and annual performance review & feedback process
• Cross-functional exposure to other areas of within the organization
• Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members
• 401K strong employer match
• Tuition Reimbursement
• Employee Referral Bonuses
• Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
• Gain experience in the cutting-edge cell therapy space

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees