Associate Director, Drug Substance Manufacturing

Job Summary

The experienced professional is responsible for drug substance process development and manufacturing support in the Technical Operation division.  Key responsibilities include oversite and technical guidance for upstream and downstream process development activities executed at CDMOs for next generation processes, technology transfer, development studies to enable process validation, and process support and trending analysis for clinical and commercial supply chain activities.  The Associate Director will be a key member within the Technical Operations team and is expected to partner with functional areas such as Analytical Development, Drug Product, Quality Assurance, Regulatory CMC and Quality Control.  The Associate Director will report to the VP, Drug Substance.

The ideal candidate will have prior experience leading late-stage drug substance process development efforts within a biotechnology company along with technology transfer of such processes to manufacturing and execution of required studies to enable Process Performance Qualification (PPQ).  The candidate should also have experience executing, authoring and reviewing key process development and process characterization studies and CMC regulatory sections for health authorities, and have a strong understanding of biologics drug substance manufacturing, regulatory expectations and guidance.  Knowledge of statistical methods utilized for process development and manufacturing process control is also important.  Liquid formulation experience is also a plus.  The individual in this role will be an important contributor to the development of late-stage drug substance manufacturing processes, collaborating within the Drug Substance team, peers in AD/QC/QC/DP/PM, and partners at CDMO and other contracted support teams.

Relationships: 

Reporting to the VP, Drug Substance.

The position will interact with all areas of CMC. In addition, clinical within Novo Nordisk.  The position interacts with team members at the IC through Vice President level.  The position requires experience interacting with senior level positions in each of these departments and a good understanding of how these peer teams operate, ideally through experience working within these teams (broad experience).

Externally, the position will engage with CDMOs.

Job Responsibilities

• Build and foster strong collaborative partnerships with CDMOs for drug substance process development, characterization and technology transfer activities.
• Aid in developing robust drug substance manufacturing processes throughout the product life cycle for Akero products.
• Ensure successful, right first time, transfer of process technologies to CDMOs and from one CDMO to another as required.
• Ensure process development studies are conducted under approaches that are reflective of regulatory guidance and agency expectations and utilizing statistical and characterization methods that are appropriate for late-stage process development.
• Review and approve DS related manufacturing documents, i.e. master batch records, change controls, plans, protocols, reports, and deviations as required.
• Support process trending analysis for existing and next-generation manufacturing processes, tying process development knowledge and experience to GMP manufacturing performance.
• Conduct CDMO site visits as required to support process development and technology transfer, conduct routine technical meetings with key stakeholders to coordinate development efforts and collaborate with partnering teams.
• Author and/or review process development global health authority dossier sections for clinical trials and commercial licensure.
• Interface with quality assurance to establish and maintain drug substance related procedural documents.

Physical Requirement:  Ability to travel up to 20%. Internationally and Domestic

Qualifications

• Bachelor's degree and 9+ years of experience OR:
  • Master's degree and 7+ years of experience
  • PhD/JD and 5+ years of experience
• Understands cGMP and GLP aspects of biopharmaceutical production.
• Experienced in process development, manufacture, and scale-up of mammalian or microbial processes, ideally in both upstream and downstream.
• Liquid formulation development expertise is a plus.
• Experience in establishment and qualification of small-scale models for manufacturing process characterization.
• Understanding of relevant protein related analytical techniques: LC, UV, CE, ELISA for product and impurity analysis.
• Excellent communication skills (both verbal and written) and interpersonal skills are required.
• Works on complex problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity.
• Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
• Maintains full working knowledge of current regulatory guidance and expectations for clinical and commercial biologics products.
• Demonstrates technical proficiency, collaboration with others and independent thought in suggesting project design and strategy.
• Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
• Demonstrates collaborative communication and problem-solving spirit.

The base compensation range for this position is $152,700 to $267,300. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.  

Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors.  

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

The job posting is anticipated to close on March 16th. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities.

EEO Statement:

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.