the smart solution for Janesville jobs

Sr. Manager,Technical Operations and Contract Manufacturing

Company: Assertio Therapeutics, Inc.
Location: Lake Forest
Posted on: March 26, 2019

Job Description:

JOB SUMMARYResponsible for commercial contract manufacturing activities at Contract Manufacturing Organizations (CMOs). This role will provide manage the technical aspects of Pharmaceutical Process, Manufacturing and Packaging activities with a focus on commercial product manufacture. Contributes to the overall strategy and planning to support tech transfer, launch, post-approval changes and routine commercial manufacturing activities and will have experience in CMO management in a development and commercial cGMP environment. 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 Subject matter Expert in Assertio's 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. RequirementsEDUCATION 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.--- 4-7 years of solid dose manufacturing experience at a manufacturing plant with 2-3 years of CMO management experience preferably in a virtual environment. --- Experience in clinical manufacturing, late-stage development, process validation and commercial pharmaceutical cGMP manufacturing environment.--- Good troubleshooting skills in various facets of process engineering, validation engineering, technology transfer, scale-up operations. --- Experience with High shear granulation, fluid bed granulation and drying, extrusion and hot-melt extrusion technologies.--- Ideal candidate will be highly cross functional and collaborative with internal and external partners.--- Experience with serialization, life cycle management of current marketed commercial products, has managed manufacturing and supply of drug product to both US and ex-US markets.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 strategiesAbout UsTHE COMPANYAssertio 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.

Keywords: Assertio Therapeutics, Inc., Janesville , Sr. Manager,Technical Operations and Contract Manufacturing, Executive , Lake Forest, Wisconsin

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Residential Manager
Description: El Valor is seeking a passionate profession to supprt our six residential facilities for adults with disabilities. The ideal candidate for this role will be passionate about serving disabled adults, familiar (more...)
Company: el valor Corp
Location: Chicago
Posted on: 04/22/2019

Alliance Marketing Manager
Description: If you're at your best working in an environment where you believe in what you do, where creativity and collaboration is the norm and you are driven to help your company grow by providing the very best (more...)
Company: CIC Plus
Location: Skokie
Posted on: 04/23/2019

Electrical Engineering Manager (Corporate)
Description: br Responsibilities will include: br --- Provide electrical engineering and technical expertise to ensure the safe and reliable operation of electric power systems in food manufacturing and processing (more...)
Company: Job Juncture
Location: Chicago
Posted on: 04/23/2019

Warehouse Manager - 3rd Shift - Naperville - 60540
Description: We're passionate about bringing the love of baking and decorating to everyone, everywhere, every day. Our message is simple we know you love baking because we do, too and we're constantly evolving (more...)
Company: Wilton Brands
Location: Naperville
Posted on: 04/22/2019

RN Case Manager - Milwaukee
Description: We Are Hiring RN Case Manager NE - Case Management 001 - Part-Time, Weekends ---St. Joseph Campus - Milwaukee, WIAdditional Details: 16 Hours/Bi-Weekly, Every Other Saturday Sunday 8 AM - 4:30 PM Why (more...)
Company: Ascension
Location: Milwaukee
Posted on: 04/23/2019

Restaurant Shift Manager - Chicago
Description: Job Description Overview GENERAL SUMMARY The Shift Manager - He/she has
Company: Raising Cane's
Location: Chicago
Posted on: 04/23/2019

Full-time Account Manager/Sales Representative
Description: Job DescriptionJob responsibilities/requirements:Building relationships with prospective clients and creating new book of businessManaging new and existing customer book of business and affiliate relationshipsCreating (more...)
Company: Flash Limousine and Buses
Location: Chicago
Posted on: 04/23/2019

Sales Manager
Description: Axiom, a pioneer in the legal industry and a leading, global provider of technology-enabled legal solutions, is seeking a Sales Manager to join our team.The RoleThe Sales Manager is a critical sales-leader (more...)
Company: Axoim Law
Location: Chicago
Posted on: 04/23/2019

RN Manager-Behavioral Health
Description: Registered Nurse Rn Float Pool - AscensionWe Are Hiring Title:--RN-SST-ExperiencedCity, State:-- Milwaukee,WILocation:-- WF - St Joseph CampusDepartment:---- Nurse Staffing 001Additional Job Details:----Full-Time,Night,--36 (more...)
Company: Ascension
Location: Racine
Posted on: 04/23/2019

Local Market Sales Manager - Chicago/Milwaukee
Description: The Local Market Sales Manager LMSM is responsible for developing and growing profitable car rental and truck rental revenue in a defined geographic territory to support ABG's off airport car and Budget (more...)
Company: Avis Budget Group
Location: Chicago
Posted on: 04/23/2019

Log In or Create An Account

Get the latest Wisconsin jobs by following @recnetWI on Twitter!

Janesville RSS job feeds