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Manager, Drug Product Manufacturing - 2nd shift

Employer
Ajinomoto Bio Pharma Services
Location
San Diego, CA
Start date
Mar 17, 2023

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Discipline
Marketing, Manufacturing & Production, Manufacturing/Mechanical
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

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 Manager, Drug Product Manufacturing to manage the day to day activities of fill & finish manufacturing. This position is responsible for implementation of all production and manufacturing equipment and procedures to optimize processes and regulatory requirements. The Manager coordinates with other departments to plan, schedule, and execute all aspects of production operations in a validated cGMP environment.

Responsibilities:

  • Oversees daily operations including formulation, filtration, filling and troubleshooting any issues.
  • Batch record review and generation (Client calls and Project Management interactions)
  • Strategic planning with DP manufacturing including defining the schedule, coordinating preparation, and troubleshooting.
  • Client calls, interactions and meetings (kick off meeting, tours, and operational issues).
  • Internal investigations (Deviations, Corrective Actions, Preventative Action, Product Quality reviews).
  • Facility planning (Shutdowns, maintenance, HEPA certifications, and media fill planning).
  • Audit Responses (Client, QP, and Regulatory Inspections, SOP and Batch record revisions).
  • Quality interactions (EM investigations, OOS investigations, 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.
  • Proactively assumes responsibility that assignments are executed properly, attaining desired outcomes on schedule and meets quality standards.
  • Builds and establishes sound working relationships with internal departments and external clients in support of company goals.
  • Supports, encourages, and collaborates with others, especially in difficult and high-pressure situations.
  • Embodies Aji Bio-Pharma Services’ cultural values and aligns daily actions with department goals and company culture.
  • 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 Services’ culture and empowers employees to take responsibility for their jobs and goals.
  • Coaches, mentors, engageand 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-Pharma Services’ policies and procedures.

    • ·

    Requirements :

  • Bachelor’s degree in scientific discipline or equivalent experience required.
  • Minimum of seven (7) years of related technical experience. Minimum of three (3) year of leadership/supervisory experience.
  • Understanding of cGMP's.
  • Understanding of regulatory requirements.
  • Solid command of chemistry including understanding of fillers and processes regarding filling.
  • Understanding of QAD, Master Control, LIMS, and RAM.

    • The anticipated salary range for candidates who will work in California is $100,738 - $141,033

    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

    Company

    At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. Our ultimate goal is to provide adaptive solutions, responsive service, trusted partnerships and peace of mind to our customers. Through innovation, accountability, compliance, communication and teamwork, we take pride in knowing our efforts are helping countless patients for years to come.

    Stock Symbol:

    AJINY  

    Stock Exchange:

    OTCMKTS

    Find Us
    Website
    Location
    11040 Roselle St.
     San Diego
    CA
    92121
    US
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