Process Engineer - Newark, CA | Biospace
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Process Engineer

Depomed, Inc.

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Location:
Newark, CA
Posted Date:
12/7/2016
Position Type:
Full time
Job Code:
723XX
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

City Newark
State California [CA]
Title Process Engineer
Job ID 723XX
Date Added 7/6/2016

Description

Responsible for supervising technology transfer and process validation activities of and will provide technical support for Depomed’s commercial products manufactured at Contract Manufacturing Organizations (CMOs). He/she will contribute to the overall strategy and planning to support site registration, process Validation, Product launch and post-approval manufacturing activities for Depomed Products. He/she will interact with Contract Manufacturing organizations and internal Depomed teams, to resolve technical manufacturing and packaging issues for commercial and clinical manufacturing activities.

ESSENTIAL JOB FUNCTIONS
• Provide input into technology transfer strategy and plans for drug products,
• Review master batch records, specifications, qualification & validation protocols and reports,
• Provide technical oversight (as person-in-plant) during the manufacture of feasibility, process optimization and validation batches at CMOs,
• Recommends process improvements to resolve manufacturing issues,
• Oversees clinical manufacturing and packaging activities.
• Collaborate with QC, QA and Regulatory for review and approval of documents for cGMP batches, including change controls
• Provides technical expertise and participates in resolution of issues that impact commercial product supply


ADDITIONAL RESPONSIBILITIES/DUTIES
• Establish/maintain effective working relationship with CMOs/business partners
• Travel estimated at 30%

Requirements

EDUCATION AND EXPERIENCE
• Bachelor’s degree in Engineering, Pharmacy or related sciences
• Minimum 2 years’ experience in technology transfer of solid oral pharmaceutical products
• Strong understanding of pharmaceutical process optimization, scale-up and manufacturing of pharmaceutical products
• Experience in working with CMOs


SKILLS AND ABILITIES
• Strong oral and written communication skills
• Strong problem solving and organization skills
• Proficiency in software such as Word, Excel, and statistical data analysis programs etc.
• 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:
• Lifting:

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.