Depomed, Inc.

Manager/Sr. Manager, Technical Operations and Manufacturing

Location
Lake Forest, IL, United States
Posted
Jun 22, 2018
Ref
1143XX
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
JOB SUMMARY
Responsible for providing Technical support for Depomed's products. Interacts with Contract Manufacturing organizations and internal Depomed teams to resolve technical manufacturing and packaging issues for commercial and clinical manufacturing activities. Will serve as the technical expert on the products under his/her responsibility and will provide feedback, guidance and solutions to questions associated with products under his/her responsibility. Will contribute to the overall strategy and planning to support site registration, process Validation, Product launch and post-approval manufacturing activities.

ESSENTIAL JOB FUNCTIONS
• Manufacturing and packaging technical support for Depomed's commercial products interfacing Commercial, Quality Assurance, Quality Control, Clinical, Regulatory. Oversees the development and manufacturing of drug products and/or transfer of development activities with CMO.
• Oversees preparation and reviews documentation, including batch records, protocols and reports. Helps generate schedules and coordination of manufacturing activities.
• Writes /reviews development and validation technical reports
• Oversees clinical trial material manufacturing and packaging activities.
• Work with Quality Systems to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements.
• Support manufacturing investigations and regulatory submissions.

Requirements

ADDITIONAL RESPONSIBILITIES/DUTIES
• Strong influence management skills including comfort operating in a highly matrix-based environment
• Attend seminars, shows, lectures, etc., that are industry or job related.

EDUCATION AND EXPERIENCE
• BS or equivalent in Chemistry, Pharmaceutical Science, Pharmaceutical or Chemical Engineering or related field. An advanced degree in sciences would be a plus.
• A minimum of 7 years of pharmaceutical or biotech industry experience, with experience in development or manufacturing of pharmaceutical products.

SKILLS AND ABILITIES
• Solid problem-solving, troubleshooting and organizational skills
• Knowledge of pharmaceutical cGMPs
• Works well within team environment.
• Effective communication skills (verbal, written, interpersonal, organizational), capable of setting priorities.
• Ability to work cooperatively with minimal supervision with internal and external groups on multiple projects

DEPOMED COMPETENCIES INCLUDE:
• Able to work in a team, get direction and give direction
• Responsive, sincere, loyal, good work ethics
• Able to cope with business limitations and challenges

PHYSICAL/MENTAL DEMANDS
• Sitting : yes
• Standing/ walking: yes
• Repetitive motion: keyboard work
• Visual Requirements: must be able to see clearly
• Lifting: no more than 40 lbs

About Us

THE COMPANY

Depomed is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of pain and neurology, and developing drugs in areas of unmet medical needs.

Depomed currently markets three medicines focused on neuropathic pain and migraine through its Neurology and Pain Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.

Depomed has a clear THREE PILLAR strategy for growth:

MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology and Pain Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.

As part of the transformation strategy, Depomed has relocated its headquarters to Lake Forest, Illinois.

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