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Pharmaceutical Development Scientist Jobs in Michigan

MMS

Senior Nonclinical Writer (US)

Canton, MI · On-site

Hands-on experience with clinical trial and pharmaceutical development preferred. * Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process. Powered ...

MMS

Senior Statistical Programmer - Remote

Canton, MI · On-site

We support the pharmaceutical, biotech, and medical device industries with our proven, scientific ... Utilizes System Development Life Cycle (SDLC) for programming deliverables. * Advanced user in SAS ...

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Pharmaceutical Development Scientist information

What does a pharmaceutical development scientist do?

A Pharmaceutical Development Scientist is responsible for researching, designing, and developing new drugs and medications. They work on formulating drug compounds, ensuring their safety and efficacy through laboratory testing, and optimizing production processes. These scientists collaborate with regulatory agencies to ensure compliance and play a key role in advancing medicines from concept to market. Their work is critical in improving healthcare outcomes and meeting regulatory standards.

What are the key skills and qualifications needed to thrive as a pharmaceutical development scientist?

To thrive as a Pharmaceutical Development Scientist, you need a solid background in chemistry, biology, or pharmaceutical sciences, often supported by an advanced degree such as a Master's or Ph.D. and relevant laboratory experience. Familiarity with analytical instrumentation (like HPLC and mass spectrometry), regulatory compliance systems (such as GMP), and data analysis software is crucial. Strong problem-solving, attention to detail, and effective teamwork and communication skills set top professionals apart. These abilities are vital for developing safe, effective medications and ensuring regulatory compliance in a highly collaborative and precise environment.

What are some common challenges pharmaceutical development scientists face when transitioning a drug from the lab to large-scale manufacturing?

Pharmaceutical Development Scientists often encounter challenges related to scaling up a drug formulation from laboratory experiments to full-scale production. This process requires careful optimization to ensure that the product maintains its efficacy, safety, and quality while being manufacturable at a commercial scale. Issues such as ingredient compatibility, process reproducibility, and regulatory compliance frequently arise, demanding collaboration with cross-functional teams in manufacturing, quality assurance, and regulatory affairs. Adaptability and problem-solving skills are essential for overcoming these hurdles and ensuring successful product development.

What is the difference between Pharmaceutical Development Scientist vs Formulation Scientist?

AspectPharmaceutical Development ScientistFormulation Scientist
CredentialsBachelor's or Master's in Pharmacy, Chemistry, or related fields; often requires experience in drug developmentBachelor's or Master's in Pharmacy, Chemistry, or related fields; focus on formulation techniques
Work EnvironmentResearch labs, development departments, pharmaceutical companiesResearch labs, manufacturing, pharmaceutical companies
Industry UsageInvolved in early-stage drug development, formulation, and process optimizationSpecializes in creating and testing drug formulations for stability and delivery

The main difference is that Pharmaceutical Development Scientists focus on the overall development and process optimization of new drugs, while Formulation Scientists concentrate specifically on designing and testing drug formulations. Both roles require similar educational backgrounds and work environments, but their core responsibilities differ within the drug development process.

What are popular job titles related to Pharmaceutical Development Scientist jobs in Michigan?

For Pharmaceutical Development Scientist jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Pharmaceutical Development Scientist jobs in Michigan look for?

The top searched job categories for Pharmaceutical Development Scientist jobs in Michigan are:

What cities in Michigan are hiring for Pharmaceutical Development Scientist jobs?

Cities in Michigan with the most Pharmaceutical Development Scientist job openings:

Pharmaceutical Development Scientist jobs near you

Process Development Scientist

Piramal Pharma Limited

Riverview, MI • On-site

Full-time

Re-posted 15 days ago

Job description

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Division
Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Process Development Scientist
Job Description
Piramal Pharma Solutions' HPAPI Research and Manufacturing facility, located in Riverview, Michigan, is seeking a qualified Process Development Scientist to join our Process Development team. The PD Scientist is responsible for the development of current and new manufacturing processes.
Key responsibilities.
  • Develop, conduct, and/or manage the process development of current and new synthetic/process pathways including routine analytical testing to monitor process progress (HPLC, NMR, XRPD, GC-HS, KF, etc.).
  • Handling of highly potent compounds and experience in synthesis and handling of Linker-Payloads is highly desirable.
  • Scale-up preparative HPLC purification and lyophilization of intermediates and final products.
  • Maintain communications with clients and ensure their requirements are met.
  • Manage/support the production of new (HP)APIs. Ensure that adequate supplies of process materials (raw materials, solvents, reagents, etc.) and operation equipment (hoses, reactors, glassware, etc.) are available for assigned tasks.
  • Ensure that product shipments meet customer and regulatory (FDA, EPA, OSHA, etc.) requirements.
  • Write progress reports and provide technical support in meetings regarding current API production and new API process development.
  • Ensure that approved processes are carried out according to cGMP guidelines and are properly documented.
  • Keep Quality Assurance and Quality Control departments updated in regard to project/client requirements and schedules. Participate in the development, training, and transfer of new processes into the plant. Maintain accurate inventories of materials.
  • Prepare appropriate reports as needed for management and/or clients.
  • Maintain notebooks for research and development and non-GMP activities. Complete and audit production and cleaning records. Complete logbooks and documentation (dispensing record, BPRs, cleaning records, deviation reports, etc.) related to production and cleaning is accordance with regulatory requirements.
  • Generate and/or evaluate standard operating procedures as required.
  • Provide technical support for chemical operators, engineering, quality control, etc.

EDUCATION/EXPERIENCE
  • To be qualified as a PD Scientist, a candidate must have:
    • PhD in Organic or Medicinal Chemistry and up to four (4) years' experience in a relevant field; OR
    • MS in Organic or Medicinal Chemistry and up to eight (8) years' experience in a relevant field; OR
    • BS in Organic or Medicinal Chemistry and up to twelve (12) years' experience in a relevant field
  • Knowledge of organic chemistry and chemical safety.

job competencies.
  • Excellent organizational and planning skills.
  • Strong written, verbal, and interpersonal communication skills.
  • Self-motivated, creative, and independent.
  • Ability to direct projects covering a variety of chemical compounds including high potent APIs.
  • Familiarity with cGMP, plant safety, and EPA requirements.

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