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Director, Drug Product Manufacturing Ops

Employer
Ajinomoto Bio Pharma Services
Location
San Diego, CA
Start date
Jun 6, 2023

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Why join Ajinomoto Bio-Pharma?

Our mission is to help improve the health of humankind.

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.

Total Rewards package designed to make your life better:

We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!

Your next career move:

We are currently seeking a Director of Drug Product Manufacturing who will be accountable for clinical and commercial drug product manufacturing operations. This is a leadership role with focus on the start-up and execution of GMP operations for all production areas, ensuring the facility is properly staffed and trained, and supporting a production planning process that is dynamic and flexible to meet the needs of Aji Bio-Pharma’s Clients. The Director will also be responsible for managing a cross-functional site leadership team, serve as a key member of various management teams within Operations, Facilities & Engineering, Quality and Product Supply Chain, and reports directly to the Vice President of Drug Product.

Responsibilities:

  • Provides leadership, vision, and management to the Drug Product Manufacturing team, and overall site.
  • Leads all aspects of drug product manufacturing operations at the facility to manufacture commercial and clinical parenteral medicines according to approved protocols, regulations, and schedules.
  • Manages key manufacturing metrics/site goals, supports critical program milestones, and drives continuous improvement initiatives that are essential to meeting client and business needs.
  • Rapidly and accurately communicates issues to Senior Leadership. Resolves manufacturing and facility issues to mitigate any supply disruptions.
  • Guides and oversees validation activities involving Drug Product Manufacturing equipment and processes.
  • Works effectively across departments, such as Quality Assurance, Facilities, Engineering, Project Management, Business Development, Regulatory, Quality Control, IT, and Supply Chain.
  • Partners with Project Management to implement new production processes. Processes may include, but are not limited to, formulation, filling, lyophilization, pre-filled syringes and finished product label and carton.
  • Oversees and approves schedules, production plans, and material requirements.
  • Ensures the effective use of material, equipment and personnel in producing quality products.
  • Collaborates with Human Resources and other functions to develop a multi-year staffing and recruiting plan for the facility.
  • Prepares and administers expense and capital budgets for the facility. Recommends capital expenditures and aids in the realization of capital projects.
  • Oversees, supports and participates in cGMP audits of all production areas within the facility.
  • Maintains site inspection readiness and represents the manufacturing facility during regulatory and client audits.
  • Writes, reviews, and/or approves SOPs, specifications, regulatory filing, or other controlled documents as needed.
  • Provides technical input to resolve manufacturing process challenges.
  • Maintains awareness of recent developments in industry, clients, competitors, and regulatory agencies.
  • Ensures that safety standards are maintained.
  • Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.
  • Requirements :

  • Bachelor’s degree in the physical or biological sciences, or chemical engineering required. Master’s degree preferred.
  • Minimum of 10 years of experience in GMP production environment.
  • Minimum of 5 years of leadership/supervisory experience.
  • Deep understanding of aseptic processes, equipment, automation, validation, cleanrooms, and other classified area requirements.
  • Highly experienced in overseeing manufacturing operations in an aseptic biologics manufacturing environment.
  • Experience with multiproduct biologics facility start-up is desired.
  • Knowledge of transferring aseptic parenteral filling, device assembly and finish label & pack operations.
  • Working knowledge of industry practices, global regulations and experience interacting with multiple health authorities (e.g. FDA, EMA, PMDA, etc.).
  • Proven ability to lead a site leadership team with cross-functional members as well as direct reports.
  • Effective cross functional collaborator (Quality Assurance, Facilities, Supply Chain, Project Management, etc.) and efficient at removing barriers.
  • Mindset and proven ability to drive inspection readiness at all times.
  • Effective at communicating to a wide audience of experience, skills and expertise. Able to communicate a vision for the site and report on progress in achieving the vision.
  • Working knowledge of financial operations in a manufacturing environment.
  • Previous experience working closely with Senior Leadership.
  • The anticipated salary range for candidates who will work in California is $145,090 - $203,126

    The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.

    If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.

    New hires will pass a background check and drug screen as a condition of employment.

    We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    #LI-KC1

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