Director of Technical Development and Contract Manufacturing - Newark, CA | Biospace
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Director of Technical Development and Contract Manufacturing

Depomed, Inc.

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Location:
Newark, CA
Posted Date:
8/19/2017
Position Type:
Full time
Job Code:
979XX
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

City Newark
State California [CA]
Title Director of Technical Development and Contract Manufacturing
Job ID 979XX
Date Added 7/24/2017
Department Technical Development & Quality

Description

JOB SUMMARY
This position is responsible for providing technical and scientific leadership for Depomed’s programs related to commercial products and clinical manufacturing, reporting to the Senior Director of Contract Manufacturing and Supply Chain. The Director is ultimately responsible for technical aspects addressing changes and improvements to Depomed’s products at Contract Manufacturing Organizations (CMOs) and oversight of clinical manufacturing and packaging activities. He/she will oversee a team of engineers/scientists that are responsible for the manufacturing of Depomed’s commercial products, lifecycle initiatives and clinical development manufacturing-related activities. In addition, the Director, will participate in the planning and execution of new programs working across the organization with Quality, Regulatory, Clinical and Marketing to introduce new products and changes to existing products.


ESSENTIAL JOB FUNCTIONS
•Technical leadership of Depomed programs, including process changes to commercial products, development programs and clinical supplies.
•Commercial Manufacturing – Develop strong relationships with Contract Manufacturers. Responsible for Development and GMP manufacturing processes, Technology Transfer, Process Validation and technical activities. Lead Contract Manufacturing selection and Contract Manufacturing qualification activities by designing a process for selection, management and monitoring of CMOs.
•Clinical Manufacturing – Manage all technical aspects of GMP manufacturing processes to produce and package clinical supplies to support clinical studies, including schedules and budgets. Ensure that processes comply with requirements of regulatory agencies. Coordinate Tech transfer and approve engineering, registration, validation activities.
•Provide technical expertise for manufacturing deviations, OOS/OOT investigations by working in concert with Quality Assurance to ensure proper disposition of affected materials.
•Implement CMC and Manufacturing activities to support lifecycle initiatives
•Provide direction and objectives to direct reports in Contract Manufacturing and Development by leading, training, and mentoring for effective performance

ADDITIONAL RESPONSIBILITIES/DUTIES
•Establish/maintain effective working relationship with CMOs/business partners
•Travel estimated at 30%
•Strong influence management skills including comfort operating in a highly matrix-based environment

Requirements

EDUCATION AND EXPERIENCE
•PhD or Bachelor’s degree in Engineering, Pharmaceutical Sciences or related sciences
•Minimum 15 years’ experience in commercial and clinical manufacturing, CMC development and technology transfer of pharmaceutical products
•Strong understanding of pharmaceutical processes, GMPs and Regulatory requirements to manufacture commercial and clinical supplies.
•Experience in working with CMOs

SKILLS AND ABILITIES
•Strong oral and written communication skills
•Strong problem solving and organization skills
•Good collaborative skills

DEPOMED COMPETENCIES INCLUDE
•Integrity
•Decisions & Judgment
•Ownership & Initiative
•Adaptability & Change Readiness
•Teamwork & Collaboration

PHYSICAL/MENTAL DEMANDS
•Sitting
•Standing/walking
•Repetitive motion
•Visual Requirements
About Us
Depomed, Inc. is a specialty pharmaceutical company focused on developing and commercializing products to treat pain and other central nervous system conditions. Founded in 1995, Depomed has successfully executed on strategy of acquiring, integrating and growing differentiated therapeutic products and building each into a strong market presence. The result is a broad portfolio of pain and neurology specialty pharmaceuticals currently comprised of five FDA-approved products. These include Gralise® for the management of Postherpetic Neuralgia (PHN), Cambia® for the acute treatment of migraine attacks, Zipsor® for the relief of mild to moderate acute pain, Lazanda® for the management of breakthrough pain in cancer patients and our most recent addition, the company’s flagship asset, the NUCYNTA® franchise.

Acquired in April 2015 and re-launched in June 2015, the NUCYNTA franchise includes NUCYNTA® ER for the extended management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN) and NUCYNTA® for immediate management of moderate to severe acute pain in adults.


Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract. The company’s Acuform technology is currently being used in four marketed drugs, including Gralise.

Depomed’s successful execution on strategy and has resulted in solid product revenue growth over the past three years. Located in Newark, California in the East Bay of San Francisco, Depomed is listed on the NASDAQ market under the ticker DEPO and employs approximately 500 people, of which approximately 350 are part of the Commercial organization.

Depomed is an AA/EEO/Veterans/Disabled employer.