Specialist III Biopharma Manufacturing Technical Support

Audentes Therapeutics • Sanford, NC

97d

About The Position

The Specialist III BioPharma Manufacturing Technical Support will be part of the Manufacturing team. The Specialist role is responsible for the support of manufacturing operations typically assigned to either Upstream, Downstream, or Filling. The incumbent will work with cross functional teams including Quality Assurance, Process Engineering, Supply Chain, and Manufacturing. The Senior Manufacturing Specialist typically reports to the Manager, Sr Manager, or Associate Director of Manufacturing.

Requirements

• BS / BA in Chemical/ Biological Engineering or Life Sciences plus 5+ years of experience in life sciences in manufacturing operations roles or Associates Degree in Science or related field with 7+ or H.S. diploma with 10+ direct related industry experience.
• Familiarity with clinical and commercial pharmaceutical manufacturing operations including Drug Substance and Drug Product operations and demonstrated experience and ability to comprehend technical information as it pertains to equipment and processes and proven ability to identify problems and apply a disciplined methodology to identify data-driven root causes.
• Prior work history requiring working independently, with minimal supervision, and working with and/or leading cross functional projects; along with proven ability to proactively adjust their work to meet changing business needs.
• Demonstrated success and desire to work with in a fast-paced environment and influential skills with coworkers and cross-functional key stakeholders.
• Strong attention to detail supported by excellent time management and organizational skills. proficiency with MS Office (Excel, PowerPoint, Word, MS Project and MS Visio), and proven ability to work in faced paced changing environment.

Nice To Haves

• 2+ years experience in the manufacture of sterile injectable products in a regulated environment.
• 1+ years experience of technical writing (nonconformances, SOPs, batch records, change controls, CAPAs, etc.).
• Experience with the following equipment: Filter integrity testers, autoclaves, Drug Product fillers and isolators, single use systems and aseptic connections.
• Hands-on experience with PUPSIT.
• Completion of the BioWork Certification Program or related industry type programs are considered a plus.
• Industry experience in Drug Substance and Drug Product and knowledge or proficiency with single use equipment and systems and cGMP and good documentation practice (GDP).
• Experience with Quality Systems, RCAs, and investigational ownership.

Responsibilities

• Responsible for manufacturing reform / updates, including SOPs and batch records, ensuring all proposed updates are reviewed / approved prior to issuance.
• Will develop and deliver GMP and/or Manufacturing-related training to Manufacturing floor staff and facilitate updates or improvements to on-the-job training platforms while ensuring training curriculum is updated to reflect current process configurations.
• Will monitor process performance metrics, investigating operational issues, escalating potential nonconformances to management and QA as deemed appropriate.
• Responsible for leading Manufacturing nonconformances in the Quality Management System, identifying true root cause of incidents and recommending appropriate corrective / preventive actions when required.
• Responsible for change records, overseeing comprehensive implementation plans for investigations and/or continuous improvement changes, ensuring processes changes are in accordance with AGT's policies and procedures, regulatory requirements, guidelines, and recommendations.
• Will work with outside vendors and internal departments (maintenance, engineering, quality, etc.) to troubleshoot equipment performance issues.
• Assists with various audits and Facility walk throughs, responses, and corrections.
• Coordinates with other departments to schedule work and other activities that impact manufacturing site milestones.
• Will design new or modify process MTL's, contribute to the population / maintenance of process descriptions, and maintain product specific sample plans for incoming clinical tech transfer programs.
• Oracle SME, responsible for the population and maintenance product specific work definitions.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree