Assertio Therapeutics, Inc.

Associate Director, Technical Operations & Mftg

Location
Lake Forest, IL, United States
Posted
Oct 27, 2018
Ref
2786350
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Overview

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.