PlymouthMARecruiter Since 2001
the smart solution for Plymouth jobs

Sr. Scientist II - Process

Company: UPSHER SMITH
Location: Plymouth
Posted on: April 8, 2021

Job Description:

Let us find jobs for you based on your skills and experiences in your LinkedIn profile. Sr. Scientist II - ProcessApply Now Category Technical Services City Plymouth State Minnesota The Technical Services Sr. Scientist II - Process Engineering leads activities related to the enhancement of existing products/processes and implementation of new product launches including execution of process validation. Directs monitoring, investigations, engagement of scale-up or post approval changes to support existing products. Render technical expertise and coordinates activities with PD for new product scale-up and manufacturing ANDA submission batches.Essential Job Duties:

  • Leads oral dosage formulation process development, process scale up and technology transfer to commercialization throughout the product lifecycle.--
  • Provides work direction and leadership to Tech Services team members.--
  • Leads change requests for resolution of production issues and deviations to ensure supply and business continuity.--
  • Supports Continuous process monitoring.--
  • Participates in troubleshooting, problem solving, failure analysis, root cause, and corrective/preventative actions. Ability to investigate deviations to determine product impact.
  • Design and conduct scientific studies to investigate exception occurrences, atypical observations, change control proposals and customer complaints.--
  • Understand and execute operation of pilot scale & commercial pharmaceutical manufacturing equipment without supervision. Duties will include the evaluation of formulation and process to determine their effects in relation to final product specification. This includes evaluating equipment set points and process parameters for their impacts on final product characteristics.--
  • Participation in formulation process evaluation early in the process development stage and participate in project risk assessments with Pharmaceutical Development and Operations. Ability to independently design, plan and execute scale up and robustness evaluation of formulation processes.--
  • Responsible for identifying and executing projects to reduce product cost, improve product quality, improve yield, and reduce material usage. Collaborates with Production, Engineering, and Quality to optimize productivity, yield, product quality, and supply reliability.--
  • Responsible for process technology training, SOP writing, technical reports and Validations.--
  • Provide training and support to Product Development personnel during the development and scale up of formulations on cGMP equipment.--
  • Conducts evaluations and experimental studies designed to develop and optimize existing product formulations and manufacturing processes.--
  • Coordinates, executes and provides the transfer of technology to the manufacturing department during the process validation.--
  • Directly involved in successive phases of developmental and transfer activities including production of R&D/DOE, scale-up, registration, component changes and process validation batches in a cGMP environment. Knowledge and experience with FDA requirements for commercialized products and awareness of current industry technology and validation practices. Demonstrated project management skills.
  • Support CMO products for off-site process validation activities including the monitoring/execution of validation batches, technical support for deviations, change controls and technical audits.
  • Assist in the generation of user requirements, functional specifications, and design specifications as required for equipment related to the supported project team.--
  • Tabulate and perform statistical analysis of all study data. Present conclusions with clear, logical, scientific explanations and justifications via technical report.--
  • Provide technical consultation and support to both Technical Services and external departments as required.--
  • Support internal, external and regulatory inspections including FDA, EMEA, and third party inspections.Requirments: Master of Science degree in Pharmaceutical Science, Pharmaceutics, Pharmacy, Industrial Physical Pharmacy, Chemistry, Pharmaceutical Engineering, Chemical Engineering, Process Engineering, or an equivalent foreign degree, with 7+ years of experience working in product development/manufacturing or process development/manufacturing in the pharmaceutical industry. A Bachelor's degree in one of the fields above with 9+ years' of the above referenced experience is acceptable. 2+ years' experience working with solid oral dosage forms, as well as 2+ years' experience working with formulation process development, process scale up, technology transfer, or ongoing pharmaceutical commercial product support. Experience can be gained concurrently. Travel requirements: Up to 25% (air travel)
    Upsher-Smith Laboratories, LLC. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category. Job ID 7927 Apply Now Our team at Upsher-Smith includes people with a wide range of talents and perspectives. Learn More We currently have openings in Manufacturing Operations Learn More Upsher-Smith is proud to support members of the U.S. armed forces. Learn More Join our Talent Community By joining our talent community, you are signing up to receive job alerts for the categories and locations you choose. Fields with an asterisk are required. Email Address Upload Resume Areas of Interest Search for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click "Add" to create your job alert. Category Location
    • Technical Services, Plymouth, Minnesota, United States Remove Upsher-Smith respects your privacy. We will not sell or rent your email address to any third party. You may opt out ofreceiving job posting alerts at any time.
      • Upsher-Smith Laboratories, LLC.,6701 Evenstad Drive, Maple Grove, MN 55369 Upsher-Smith Laboratories, LLC. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

Keywords: UPSHER SMITH, Plymouth , Sr. Scientist II - Process, Other , Plymouth, Massachusetts

Click here to apply!

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

I'm looking for
in category
within


Other Other Jobs


HHA Companion - Great Pay FULL Benefits
Description: Our rapidly growing team is looking to hire both new and experienced caregivers in your area Offering a wide range of scheduling options including full-time, part-time, daytime, evening, and weekend shifts, (more...)
Company: CareInHomes
Location: Salem
Posted on: 04/12/2021

Sprinkler Apprentice - Taunton, MA
Description: Company Overview: At ADT Commercial, we are in the business of helping people and organizations to protect what matters most to them. Building upon ADT's 145-year legacy, we secure the livelihoods and (more...)
Company: ADT
Location: Taunton
Posted on: 04/12/2021

Team Member
Description: Looking for a fun job Are you an outgoing people
Company: Dunkin
Location: Weymouth
Posted on: 04/12/2021


Order Picker/Packer - All Full Time Shifts Start at 1:20am
Description: Delivery Warehouse Team Member br Location: br Middleborough, MA br Job opportunities vary by location. We update postings daily with open positions. br br Hourly pay rate: br 15.00/hr- (more...)
Company: Amazon
Location: Taunton
Posted on: 04/12/2021

Sr. Associate, Credit Risk (Auto)
Description: The Sr. Associate, Credit Risk is responsible for partnering with the accountable business owner within 1st line of defense Risk Management and Controls. S/he is responsible for the remediation of the (more...)
Company: Santander Holdings USA Inc
Location: East Providence
Posted on: 04/12/2021

Front of Store Attendant
Description: Front of Store Attendant 387603878 Taunton, Massachusetts, US, 02780 Lot Associates assist customers with
Company: The Home Depot
Location: Taunton
Posted on: 04/12/2021

Lot Associate
Description: Job Description Lot Associates assist customers with the loading of their vehicles and also monitor
Company: The Home Depot
Location: Taunton
Posted on: 04/12/2021

Center-Based Clinician - Part-time
Description: Bay State Community ServicesDescription: br Bay State Community Services BSCS is the safety net agency that is committed to helping those most in need. If you are looking to be part of a non-profit (more...)
Company: Bay State Community Services
Location: Plymouth
Posted on: 04/12/2021

Travel Rad Tech
Description: Emerald Health Services is seeking an experienced Rad Tech for an exciting Travel Allied job in Salem, MA. Shift: Inquire Start Date: ASAP Duration: 13 weeks Requirements:1 years About Emerald Health (more...)
Company: Bluepipes
Location: Salem
Posted on: 04/12/2021

Magnetic Lap
Description: Description:Must Haves1 year of manufacturing experienceThe candidate will have to work off a daily work order to polish parts. Minor sandblasting basic inspection with micrometers and visuals. Will cross-train (more...)
Company: Aerotek
Location: East Providence
Posted on: 04/12/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Plymouth RSS job feeds