Associate Director, Technical Operations & Mftg
- Employer
- Assertio Therapeutics, Inc.
- Location
- Lake Forest, IL, United States
- Start date
- Nov 26, 2018
View more
- Discipline
- Manufacturing & Production, Operations
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest
Job Details
ESSENTIAL JOB FUNCTIONS
- Manages and oversees tech transfer, launch, post-approval changes and routine commercial manufacturing activities at CMOs
- Oversees and plans product needs to ensure timely supply. Assist in preparation schedules and coordination of manufacturing activities.
- Technical leadership in Assertio products with emphasis in process and manufacturing activities.
- Helps create a manufacturing strategy for Assertio's products, interfacing with Quality, Clinical, and Regulatory groups.
- Writes/reviews batch records and protocols for manufacturing of drug products.
- Writes /reviews development and validation technical reports
- Oversees clinical trial material manufacturing and packaging activities and manages budgets for those projects.
- Works with Quality Systems to ensure implementation and maintenance of quality standards, meeting compliance/regulatory requirements.
- Supports manufacturing investigations and regulatory submissions.
ADDITIONAL RESPONSIBILITIES/DUTIES
- This position will require up to 35 % travel to contract manufacturing facilities in the US and ex-US.
Responsibilities
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 10 years of pharmaceutical or biotech industry experience, including late-stage development, process validation and commercial pharmaceutical cGMP manufacturing environments
- Prior experience related to managing external CMOs is required.
- Prior experience in working at a commercial manufacturing site is a plus
SKILLS AND ABILITIES
- Solid problem-solving, troubleshooting and organizational skills.
- Strong knowledge of pharmaceutical cGMPs.
- Experience in leading cross-functional CMC teams to accomplish department goals
- Effective communication skills (verbal, written, interpersonal, organizational), capable of setting priorities and managing high workload projects
- Familiarity with risk management strategies
- Ability to work strategically and independently with internal and external groups on multiple projects
DEPOMED COMPETENCIES INCLUDE
- Integrity
- Decisions & Judgment
- Ownership & Initiative
- Adaptability & Change Readiness
- Teamwork & Collaboration
Requirements
THE COMPANY
Assertio Therapeutic 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 neurology, orphan and specialty therapies.
Assertio has a clear THREE PILLAR strategy for growth:
MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology 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.
Assertio is an AA/EEO/Veterans/Disabled employer.
Company
Assertio reflects an aspirational mindset that is forward thinking, energetic, and entrepreneurial in spirit. The Assertio mission of advancing patient care is reflected in our three-pillar strategy:
Maintain
Grow
Build
Maintain
In December 2017, the Company announced the signing of a definitive Commercialization Agreement with Collegium Pharmaceutical under which Collegium will commercialize the NUCYNTA pain franchise and Assertio will receive a royalty rate on all NUCYNTA revenues based on certain net sales thresholds.
Our long-term strategy is to continue to identify, license, develop and market distinctive products that offer enhanced therapeutic options for patients in need—all while maintaining the highest ethical standards in all our business practices.
We have developed and are licensing Acuform® technology, a patented oral delivery technology that allows for targeted, extended release of compounds into the upper GI tract. Acuform is currently utilized in four marketed products, including NUCYNTA ER and Gralise. To date, we’ve also licensed Acuform to six partners
Grow
We currently market three FDA-approved products for various neurological conditions.
Build
We have created a new specialty products business unit, with the objective of assembling a portfolio of specialty/orphan drugs that address the unmet needs of patients, physicians and payers. Our initial focus is the development of Cosyntropin (synthetic ACTH depot), a unique, late-stage product that, upon approval, will provide U.S. patients, physicians and payers with an alternative option.
NASDAQ: ASRT
- Website
- http://www.assertiotx.com/
- Phone
- 224-419-7106
- Location
-
100 South Saunders Road, Suite 300
Lake Forest
Illinois
60045
US
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