Director Manufacturing Operations
Catalent Pharma Solutions - Somerset, NJ

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Catalent Pharma Solutions (a Blackstone Group company) is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry. A Fortune 1000 company, with over 20 locations on 5 continents, we partner with 90 out of the top 100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as thousands of small innovator companies.

SUMMARY OF ESSENTIAL FUNCTIONS: This position is responsible for:

Directing and providing scientific and technical leadership for the overall manufacturing and pilot plant operations of the Oral Solids, Zydis® and Softgel technologies at the site, and to support customer-driven product development and commercial work for the Pharmaceutical Development Center at Somerset NJ.

Organizing, managing and improving Operations activities in support of the development of new products or processes and the manufacture of clinical and commercial products according to cGMPs in a timely manner, right first time in accordance with Business Unit objectives.

Maintain the operational facility in the highest level of cGMP compliance per FDA, MHRA and customer expectations.

Ensuring the full compliance to OSHA and cGMP regulations of the entire manufacturing operations at all times and working in concert with QA, Engineering and Supply chain to ensure that the manufacturing operations area is performing as required to meet customer commitments.

Working with the Metrology, Engineering and Facilities groups on site ensuring compliance and effectiveness through maintaining appropriate Engineering standards, maintenance and calibration of equipment according to all required standards.

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Direct Softgel, Zydis® ODT and Oral Solids manufacturing staff to ensure the timely delivery and right first time execution of manufacturing operations for development projects and commercial batches.

Ensure that all operations are compliant with Catalent Safety Standards and OSHA 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.

Assist the Site GM in establishing strategic directions for manufacturing resources and activities, and setting objectives to maximize the value of the organization's contributions.

Ensure continued operational efficiencies are realized with reliable schedule adherence, lower conversion cost and increased productivity.

Establish priorities and assure adequate resources to complete projects in a timely manner.

Provide technical direction and support to the Business Development group by assisting in securing customer-funded projects through participation at customer meetings relating to all technologies.

Assist in the introduction of new technologies, which extend the application of Oral solid drug delivery systems, Zydis ODT drug delivery systems and Softgel Technology and other services as required.

Represent the organizational unit as the prime internal and external contact for site manufacturing operations.

Maintain good communication and working relationships throughout the division and corporation.

Ensure there are daily, weekly, monthly and quarterly manufacturing operations meetings to drive safety, 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 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 which are directly/potentially applicable to Oral Solids, Zydis ODT products, Softgel Technologies services, and technologies.

Other responsibilities as assigned.

Qualifications

POSITION REQUIREMENTS:
Education: BS/BA/MS/PhD degree in Pharmaceutical Science or Chemistry/Life Science. Alternatives are minimum of fifteen to twenty years experience or equivalent training and work experience that provides a working knowledge base of managing on a day to day basis Pharmaceutical manufacturing operations for commercial and development processes.

Experience: A minimum of 15 years experience in Pharmaceutical Operations with 5 years of this being in a managerial position. Significant experience with Oral Solid Dose manufacturing and production processes and equipment. Experience in deviation and technical investigations and managing teams of >25 is necessary. Experience in logistics/planning of clinical manufacturing operations is preferred. Working knowledge of containment strategies for highly potent compounds would be advantageous.

Knowledge/Skills:
Has completed Lean and/or Black Belt certifications.

Clear leadership qualities and demonstrated success in management of change.

Has extensive understanding of pharmaceutical industry and contract services business issues and trends. External/internal recognition in broad area of expertise; acknowledged expert with proven insight in extending boundaries of existing knowledge.

Has intimate knowledge of practices and interpretation of legal and regulatory requirements of OSHA and Food and Drug Administration federal agency.

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.

Must have working knowledge of best in class clinical supply operations. Supervises: Group Leaders: Zydis Operations, Oral Solids Operations, Softgel Operations and Technical Services personnel.

Physical/Mental Requirements:
Mathematical and reasoning ability.

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Ability to work effectively under extreme pressure to meet deadlines.

Overall above average intelligence, creative thinker with sound of business judgment. Good negotiation and reasoning skills.

Excellent written and verbal communications skills. Ability to easily learn and retain technical information.

Well organized with ability to handle multiple activities simultaneously.

Individual may be required to sit, stand, walk regularly and occasionally lift 0-35 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Work Environment: Individual's primary workstation is located in the office area, where the noise level is low. Employee will be present on the laboratory and manufacturing floors for extended periods of time where the noise level is low to moderate.

Catalent Pharma Solutions - 19 months ago - save job - block
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Catalyst + talent = Catalent. At least, that's the brand Catalent Pharma Solutions is using to try to ensure its customers'...