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Full Time Downstream Process Development Scientist Jobs in Michigan

Dicastal North America

Process Engineer

Livonia, MI · On-site

... development, complemented by knowledge of machining and assembly processes. The primary focus of ... supporting downstream machining and assembly operations to ensure seamless product ...

MMI Engineered Solutions

Process Engineer

Warren, MI · On-site

Lead process development and validation for all new injection molds using Scientific Injection Molding techniques * Collaborate with Engineering, Quality, and Production teams to establish stable ...

MMI Engineered Solutions

Process Engineer

Warren, MI · On-site

Lead process development and validation for all new injection molds using Scientific Injection Molding techniques . * Collaborate with Engineering, Quality, and Production teams to establish stable ...

MMI Engineered Solutions

Process Engineer

Warren, MI

Lead process development and validation for all new injection molds using Scientific Injection Molding techniques . * Collaborate with Engineering, Quality, and Production teams to establish stable ...

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Full Time Downstream Process Development Scientist information

What does a Full Time Downstream Process Development Scientist do?

A Full Time Downstream Process Development Scientist is responsible for designing, optimizing, and scaling up processes that purify biological products such as proteins, antibodies, or vaccines after they are produced in cells or microbes. This role involves developing and improving techniques like filtration, chromatography, and centrifugation to ensure high purity and yield of the final product. The scientist also conducts experiments, analyzes data, and collaborates with cross-functional teams to transfer processes from the lab to manufacturing. Their work is critical for producing safe and effective biopharmaceuticals on a large scale.

What is the difference between Full Time Downstream Process Development Scientist vs Downstream Process Engineer?

AspectFull Time Downstream Process Development Scientist
Primary FocusDesigning, optimizing, and developing downstream purification processes for biopharmaceuticals
Required CredentialsBachelor's or Master's in Biotechnology, Biochemistry, or related field; experience in process development
Work EnvironmentLaboratories, R&D settings, collaborative teams in biotech or pharma companies
Typical ResponsibilitiesProcess scale-up, method validation, troubleshooting, documentation

While both roles involve downstream bioprocessing, the Full Time Downstream Process Development Scientist focuses on process development and optimization, whereas the Downstream Process Engineer typically handles process implementation and manufacturing support. The scientist role emphasizes research and development, while the engineer role is more operational. Candidates often hold similar degrees and certifications, but their daily tasks and focus areas differ.

What are some typical challenges faced by a Downstream Process Development Scientist, and how can they be addressed?

Downstream Process Development Scientists often encounter challenges such as optimizing protein purification processes to achieve high yield and purity, troubleshooting unexpected impurities, and scaling up processes from laboratory to manufacturing scale. These tasks require strong problem-solving skills, meticulous attention to detail, and effective collaboration with upstream teams, analytical scientists, and manufacturing staff. Addressing these challenges involves staying current with new purification technologies, maintaining robust documentation, and participating in cross-functional meetings to ensure seamless process integration and regulatory compliance.

What are the key skills and qualifications needed to thrive as a Full Time Downstream Process Development Scientist, and why are they important?

To thrive as a Full Time Downstream Process Development Scientist, you need a strong background in biochemical engineering, protein purification, and analytical techniques, typically supported by a degree in biochemistry, biotechnology, or a related field. Proficiency with chromatography systems (e.g., HPLC, FPLC), filtration technologies, and knowledge of regulatory and quality systems like GMP is essential. Strong problem-solving abilities, teamwork, and effective communication skills help you collaborate with cross-functional teams and troubleshoot process challenges. These skills are crucial for developing robust purification processes that ensure product quality, regulatory compliance, and efficient production in biopharmaceutical environments.
What are the most commonly searched types of Downstream Process Development Scientist jobs in Michigan? The most popular types of Downstream Process Development Scientist jobs in Michigan are:
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Full Time Downstream Process Development Scientist jobs near you

Process Development Scientist

Piramal Pharma Limited

Riverview, MI • On-site

Full-time

Posted 28 days ago

Job description

Be the First to Apply
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.

Apply