Associate Director, Technical Operations Drug Substance

Job Description

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69000 employees operating in more than 140 countries we offer state-of-the-art laboratories manufacturing plants and offices designed to inspire our employees as we learn develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the worlds biggest investors in Research & Development.

We are seeking individuals with strong scientific and technical skills to contribute to the design development and manufacturing of sterile products making accessible our companys next generation of vaccines and biologics. To this end we strive to create an environment of mutual respect encouragement and teamwork. As part of our team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We have an exciting opportunity for an Associate Director to join the technical operations team supporting a start-up of Human Health at our facilities in Durham North Carolina. This new facility will include end-to-end processing of both drug substance and drug product and quality control laboratories.

The Associate Director Technical Operations will be responsible for providing technical leadership to the drug substance manufacturing area as part of the Technical Operations team.

Responsibilities

• Reporting to the Director Technical Operations the incumbent will assist in strategy development and will independently manage project assignments.
• Effectively manage a team of engineers and scientists supporting drug substance technical transfer by developing a culture that defines a High-Performing Organization including proactively providing developmental support coaching and assistance to team members.
• Provide end-to-end technical support to assigned areas of focus throughout the project lifecycle including but not limited to quality risk management strategy development development of standard operating procedures and master batch records process development and process performance qualification.
• Lead facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.
• Review and approve project documents as necessary including drug substance and process support and media technical documents documents pertaining to utilities manufacturing equipment and other processes change controls batch records standard operating procedures corrective and preventative actions among others.
• Act as a subject matter expert in support of quality risk assessments and regulatory inspections.
• Supports team safety environmental and compliance objectives.
• Escalates and consults on an as-needed basis with next level manager on more complex decisions impacting critical project milestones.

Qualifications

Required

• Bachelors Masters or Doctorate degree in chemical engineering biochemical engineering biological systems engineering biology biochemistry chemistry or related life science or engineering discipline.
• Minimum of four (4) years (Doctorate) six (6) years (Masters) or seven (7) years (Bachelors) experience in pharmaceutical operations technical services and/or quality operations including prior people management experience.
• Effective decision-making problem-solving and communication skills.
• Ability to manage multiple priorities and complex problems in a fast-paced environment.
• Aseptic manufacturing and GMP manufacturing experience preferably with biological drug substance.

Preferred

• Capital project experience.
• Experience using Lean/Six Sigma tools.

Required Skills:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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