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Director, Manufacturing Operations

About Catalent San Diego

Catalent San Diego, Inc. (Formerly Pharmatek Laboratories, Inc.) is a premier pharmaceutical chemistry development and manufacturing organization supporting the pharmaceutical and biotechnology industries. Catalent San Diego focuses on bringing client drug compounds from discovery to the clinic with services that include analytical development, preformulation testing, formulation development, GMP manufacturing and stability storage and testing.

At Catalent San Diego, we recruit and develop exceptional individuals with a passion for science and determination to excel. We offer a technically challenging and stimulating environment and the opportunity to learn from the best. We provide a generous benefits package, on-site gym and fitness programs, team sports, activities and competitive compensation.

Director, Manufacturing Operations

The Director Operations leads the manufacturing function at the site and is responsible for providing strategic, operational and technical leadership for the overall manufacturing operations. 

As a critical member of the Site Leadership Team, is responsible for the operational and compliance performance necessary to drive growth and customer excellence and PATIENT FIRST culture.  Working cross-functionally with Quality, Engineering, Pharmaceutics, Supply Chain, HR, Continuous Improvement and Finance, will be responsible for organizing, managing and improving Operations activities in support of the development of new products or processes and the manufacture of clinical and products according to cGMPs and right first time in accordance with Business Unit objectives. Responsible for building strong working relationships across the site and driving employee and customer engagement to next level and ultimately delivering safe and effective products to patients.

The role is responsible for building both a high performing team and high performing systems in order to drive and sustain business growth and to meet the demands of a complex customer base.

Preferred candidates will have significant opportunity based on performance and demonstrated leadership to be considered for progressive leadership roles at a rapidly growing site.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Direct manufacturing staff to ensure the timely delivery and right first time execution of manufacturing operations for development projects and manufacturing batches.
  • Ensure that all operations are compliant with Catalent EHS and Security Standards and OSHA and EPA requirements at all times.
  • Maintain the operational facility in the highest level of cGMP compliance per FDA, MHRA and customer expectations.
  • Ensure Operational teams are adequately trained, knowledgeable and competent to perform all task requested.
  • Build, maintain and motivate a multi technology operations team capable of achieving all productivity targets and output requirements to service customers with product on time – In Full and Right First Time.
  • Partner with Facilities, Engineering, Metrology and Maintenance groups to ensure effective standards are maintained for the maintenance and calibration of equipment/facilities to support manufacturing.
  • Assist the Site GM in establishing strategic direction for manufacturing resources and activities, and setting objectives to maximize the value of the organization's contributions by adapting new technologies, capabilities and smart automation.
  • Ensure continued operational efficiencies are realized with reliable schedule adherence, lower conversion cost and increased productivity driving down the number of rejected/reprocessed batches and API losses.
  • Establish priorities and assure adequate resources to complete projects in a timely manner.
  • Partner with Engineering, Quality and Development in the introduction of new technologies.  
  • Represent the organizational unit as the prime internal and external contact for site manufacturing operations.
  • Ensure there are daily, weekly, monthly and quarterly manufacturing operations meetings to drive EHS, cGMP compliance and adherence to plan.
  • Complete investigations in a timely manner and ensure root causes are correctly identified.
  • Represent Manufacturing operations on the Site Leadership Team.
  • Share responsibility for short and long term resources and facility planning, and perform managerial duties as required, e.g. budgets, personnel performance appraisals, etc.
  • Work directly with Validation, Quality Assurance, Analytical Services, Engineering, and Project Management functional areas to plan and implement the execution of cGMP activities in manufacturing operations for both development processes and commercial operations.
  • Work on complex problems of diverse scope where analysis of data requires evaluation of intangible factors.  Exercises independent judgment in developing methods, techniques and evaluation criteria.  Demonstrates success in technical proficiency, creativity, collaboration with others and independent thought.
  • Monitor and report progress of projects within agreed upon time lines, ensuring customer and Company objectives are met.
  • Responsible for participating and representing all manufacturing operations in Pre-approval Inspections, FDA, MHRA and other Regulatory  audits and client audits.
  • Develop quality and business metrics for assessing productivity/profitability of manufacturing.
  • Develop and manage the budget requirements for each fiscal year.  Agree with GM and organize the purchase of appropriate capital items as required for projects.
  • Use Lean Six Sigma tools in day to day operations and to improve the operation according to the Site plan.
  • Ensure all company and site policies are adhered to and ensuring appropriate company disciplinary policies are followed consistently.
  • Liaise with vendors and suppliers as a technical representative.
  • Keep abreast of technical and regulatory developments in the pharmaceutical field.
  • Other responsibilities as assigned.

Requirements:

  • Requires minimum B.S. in life sciences, ideally Chemistry, Biochemistry, Pharmacological Chemistry or Biology
  • 10+ years’ experience in Pharmaceutical Operations with 5 years of this being in a managerial position.
  • Significant experience with Oral Solid Dose manufacturing and production process and equipment.
  • Experience in deviation and technical investigations and managing teams of >20 is necessary.
  • Experience in logistics/planning of clinical manufacturing operations is preferred.  
  • Working knowledge of containment strategies for highly potent compounds would be advantageous.
  • Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor; strong interpersonal skills and political savvy.
  • Strong business orientation and financial skills. 
  • Excellent negotiation and contracting skills. 
  • Ability to “get the job done” and take responsibility for results without direct authority. 
  • Ability to coordinate, facilitate and organize resources. 
  • Ability to develop strategic relationships; strong verbal and written communication skills; excellent presentation skills. 
  • Superior customer service orientation with strong follow-up skills and attention to detail. 
  • Willingness to travel.
  • Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.
  • Experience working in a functional matrix and BU structure

 About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products.  With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: 

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

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