Sr Scientist II - PD

Upsher-Smith Laboratories, Inc. Maple Grove , MN 55369

Posted 4 weeks ago

T042-4B

The Senior Scientist II will play a critical role as the subject matter expert (SME) and project lead of Pharmaceutical Development. The position will be responsible for preformulation studies, formulation and process development, optimization, scale-up and manufacturing in support of USL's growing pipeline of ANDAs and 505b2 products. The Senior Scientist II, must be able to collaborate effectively with a multidisciplinary team of scientists and engineers for formulation and process optimization and overall product development. Effective communication skills are essential for interactions with scientists and colleagues from numerous functions, serving on multi-disciplinary project teams.

Duties:

  • Lead formulation development and optimization studies for solid oral dosage forms, liquids and suspensions by utilizing QbD principles.

  • Accountable for process optimization and scale-up activities, design space definition and technology transfer to commercial plant.

  • Serve as subject matter expert (SME) with internal team members and be able to clearly explain the purpose of experiments and experimental results to senior management and non-scientists within the company.

  • Prepare, review, and/or approve study protocols, study reports, manufacturing batch records, development campaign reports, CMC regulatory submission documents and SOPs.

  • Collaborate with cross functional teams including but not limited to Analytical Development, Technical Services, QA, Project Management and Regulatory to timely achieve project goals.

  • Proactively demonstrate leadership by advising and sharing knowledge and expert opinions with peers and senior management.

  • Ensures all development projects and deliverables are completed within established timelines, budgets, resources, and in accordance with regulatory, quality, and safety requirements.

  • Responsible to document all data generated in the laboratory notebooks.

  • Assist in maintaining high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position.

  • Perform miscellaneous technical and administrative duties as required to meet company objectives.

Requirements:

  • Bachelors, Masters, or PhD in Pharmaceutical Sciences or related field with 9-13 (Bachelors), 7-11 (Masters), or 4-7 (PhD) years of industry experience. Candidates with PhD are strongly preferred.

  • Demonstrated extensive experience in formulation/process development and scale-up of solid oral dosage forms, liquids and suspensions.

  • Experience with development of semisolids and injectables is preferred.

  • Hands-on in oral drug product manufacturing unit operations including blending, wet- and dry-granulation, tableting, film-coating, milling, wurster coating.

  • A thorough understanding of cGMP, regulatory and safety requirements.

  • Proven ability to interpret experimental results to form appropriate recommendations and provide guidance on next experiments; prioritize tasks to align with company strategy.

  • Demonstrated leadership of technical teams and effective cross-functional communication.

  • Proven ability to solve critical business and scientific problems.

  • Strong interpersonal, communication, and project management skills with the ability to interact effectively with a cross-functional team.

Other Skills and abilities:

A history of achievement in pharmaceutical industry with an ability to multitask. Critical thinking, effective communication and organizational skills are essential for this role.

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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr EHS Specialist

Jabil Circuit

Posted 6 days ago

VIEW JOBS 5/21/2020 12:00:00 AM 2020-08-19T00:00 At Jabil, we empower the brands who empower the world - it's our reason for being and the guiding force that's driving us to become the most technologically advanced manufacturing solutions provider on the planet. Whether we're serving one of the world's biggest and best known brands or the coolest tech startups, our resolve never wavers. We share common desires with these brands: to make the world a better, safer and cleaner place. JOB SUMMARY The Sr EHS Specialist is responsible for coordinating, implementing, improving and verifying programs that support our environmental, health and safety systems. ESSENTIAL DUTIES AND RESPONSIBILITIES * Manages programs that support Jabil's environmental and safety goals. Areas of responsibility may include accidents, emergency response, hazardous communications, radiation safety, industrial trucks, personal protective equipment, exposure assessment, job hazard analysis, process safety review, machine guarding, hazardous energy isolation, air pollution, waste water management, water pollution control, environmental sustainability, hazardous waste, DOT hazardous materials rules, or other areas regulated by the United States Environmental Protection Agency, the United States Occupational Safety and Health Administration, or the Pipeline and Hazardous Materials Safety Administration. * Maintains record keeping systems * Conducts training in all Environmental, Health, & Safety topics * Conducts inspections and audits and recognizes hazards * Participates in and leads emergency responses and addresses employee Environmental, Health, & Safety concerns * Implements Environmental, Health, & Safety measures, programs, and procedures * Maintains metrics and KPIs, prepares technical reports, performs sampling and monitoring, and issue hot work permits and confined space permits. * Develops and maintains programs to support regulatory requirements and Jabil goals, by: o Analyzing federal, state and local legal requirements and developing programs to support compliance o Ensuring persons involved in programs are competent and addresses issues to increase compliance and conformance with company expectations o Documenting programs by writing, revising and maintaining work instructions, procedures, visual aids o Maintaining records of program as required by law and internal procedures o Determining effectiveness of programs through the collection and analysis of data and developing and implementing corrective actions based upon analysis o Prepares reports for submission to Corporate or regulatory bodies o Inspects and audits for compliance * Interacts with internal and external customers, including facilitating government inspections, and providing information to government inquiries * Integrates all activities into the environmental, and health and safety management systems, monitoring record keeping and reporting * Develops solutions to environmental or safety concerns * Serves as a subject matter technical resource to all levels of the organization in assigned area * Supports unassigned EHS programs as necessary * Adheres to all safety and health rules and regulations associated with this position and as directed by supervisor. * Comply and follow all procedures within the company security policy * May perform other duties and responsibilities as assigned. EDUCATION AND EXPERIENCE REQUIREMENTS * Associate's or Bachelor's degree in Occupational safety and health, environmental safety and health, safety or environmental management, and safety or environmental science preferred. (ABET Accredited) * Minimum five (5) years experience * Associate Safety Professional, Occupational Health and Safety Technologist, or Certified Safety Professional preferred * A basic knowledge of industrial hygiene (IH) and engineering principles, understanding of the theory behind machine guarding and Lockout/Tagout electrical safety, knowledge of regulatory compliance laws, and computer skills. Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law. Jabil Circuit Maple Grove MN

Sr Scientist II - PD

Upsher-Smith Laboratories, Inc.