Supervisor, Drug Product Manufacturing - 2nd Shift

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 Drug Product Manufacturing Supervisor - 2nd Shift who is responsible for the implementation of all production and manufacturing procedures to optimize processes and regulatory requirements. This position coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment.

Responsibilities:

• Oversee daily operations (formulation, filtration, filling and troubleshooting of any issues).
• Batch record review and generation.
• Strategic planning with drug product manufacturing and other internal teams including defining schedule, coordinating preparation, and troubleshooting any issues that may arise.
• Participate in client calls, interactions and meetings including kick off meeting, tours, and resolving operational or quality issues.
• Participate in internal investigations including deviations, corrective actions, preventative actions, and product quality reviews.
• Facility planning for shutdowns, maintenance, HEPA certifications, qualifications and media fill planning.
• Provide audit responses related to Client, QP, and Regulatory Inspections, SOP and Batch record revisions.
• Interact with the Quality team regarding EM investigations, OOS investigations, and deviation Investigations
• 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.

Leadership Responsibilities:

• Directs and provides expert knowledge in the day-to-day function of Drug Product Manufacturing.
• Identifies, recruits, and retains top-notch talent.
• Champions Aji Bio-Pharma's culture and empowers employees to take responsibility for their jobs and goals.
• Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
• Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
• Maintains transparent communication. Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
• Provides oversight and direction to the employees in accordance with Aji Bio-Pharma's policies and procedures.

Requirements:

• Bachelor's degree in life sciences discipline or equivalent required
• Minimum of five (5) years of experience in relevant technical experience
• Minimum of 1 year leadership experience.
• Understanding of cGMP's.
• Understanding of regulatory requirements.
• Solid command of chemistry.
• Understanding of fillers and processes regarding filling.
• Understanding of QAD, ACE, LIMS, and RAM.

The anticipated salary range for candidates who will work in California is $85,867 - $112,700.

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 be asked to complete a background check and drug screen as a condition of employment.

For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO

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.

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