Manufacturing Supervisor | BioDuro-Sundia

Department: Manufacturing

Title: Manufacturing Supervisor

Reporting to: Manager of Manufacturing

Classification: Full Time

What We Do

BioDuro is a privately-owned Contract Research, Development and Manufacturing Organization (CRDMO) headquartered in San Diego, CA with more than 1,200 employees globally. Our four facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Discovery Chemistry, Biology and Animal DMPK services through our Chinese facilities, to Formulation Development and cGMP Manufacturing of oral solid dosages, nebulized and inhaled products, gels and topical ointments at our San Diego Headquarters, there is no surprise BioDuro is a leading partner of choice.

Why BioDuro?

Take the next step in your career and join BioDuro today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Position Summary

The Supervisor of Manufacturing is responsible for supporting clinical and commercial activities based on manufacturing and product development schedule, and that is compliant with cGMPs and safety regulations. This position is responsible for providing guidance and supervision to the Manufacturing team, initiating and approving investigations generated by the manufacturing group, and proposing and implementing corrective and preventative actions as required to prevent a recurrence. This role is also responsible for driving continuous improvement for manufacturing by developing, revising, maintaining, organizing and monitoring quality systems of the Manufacturing Support Group by performing specific tasks or by overseeing others in the performance of those tasks.

Essential Job Functions

  • Oversees the utilization of production equipment/instrumentation to manufacture/process drug products by the Code of Federal Regulations, company policies and procedures, and safety codes.
  • Provide strategic, scientific and managerial leadership for manufacturing operations.
  • Manage manufacturing activities, assign projects to appropriate teams and provide direction to solve complex manufacturing technical issues
  • Coordinate transfer of formulation and process development activities to GMP manufacturing.
  • Initiate and approve investigations relating to the root cause of manufacturing deviations.
  • Participate in the development of new processes, issue resolution, and manufacturing design review transfers.
  • Provide manufacturing support on the customer complaint investigation process.
  • Actively participate in audits (internal and external) related to manufacturing.
  • Assist manufacturing in identifying, developing and implementing OPEX and process improvement projects
  • Responsible for the maintenance of a safe, accident-free work environment. Devise, manage, and coordinate training programs or media, which will increase proficiency in safe practices and promote safety consciousness. Be familiar with Material Safety Data Sheets (MSDS) on area chemicals and ensure familiarity of employees with MSDS use.
  • Assist in reviewing and completing all documentation is following GMP
  • Independently trains and supports operators in implementation of new production and manufacturing procedures
  • Provides routine updates to clients and management

Education & Experience

  • Bachelor’s degree (Manufacturing Management, Engineering or Pharmacy preferred) and, a minimum of 3 years of experience in a pharmaceutical manufacturing environment.
  • 2 – 5 years manufacturing, engineering or quality systems experience supporting manufacturing of solid dosage products and drugs.
  • A minimum of 10 years of pharmaceutical industry experience, with demonstrated capabilities in team leadership for at least 5 years.
  • Pharmaceutical/FDA regulated environment experience necessary.
  • Working knowledge of GMP and Quality

Skills

  • Ability to lift up to 75 lbs or manipulate 150 lbs or more.
  • Stand for 8 – 10 hours per day
  • Ability to be respirator certified
  • Manages personal and interpersonal stress
  • Has good verbal and written communication skills
  • Able to lead and assist in training others
  • Able to be flexible and adapting to process schedules based on business needs

SUPERVISION AND LEADERSHIP

  • Manage a team of manufacturing operators

WORKING CONDITIONS

Well-lit, heated and/or air-conditioned indoor office and manufacturing setting with adequate ventilation.

Exposure to dirt, dust, heat, noise, fumes, odors, and vibrations.

Position Benefits

BioDuro employment provides the opportunity to work in beautiful San Diego, California only 5 minutes from the nearest beach, with the possibility of international travel to our facilities in Jiangsu, Shanghai, and Beijing. We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro provides employees with free catered lunch Monday through Thursday, and a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing careers@bioduro.com. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives

BioDuro is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

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