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Director Of Process Development Jobs in Michigan

As a member of our global team, you can expect exciting, varied responsibilities as well as a wide ... The Process Development Engineer (Assembly) will be responsible for designing, developing ...

As a member of our global team, you can expect exciting, varied responsibilities as well as a wide ... The Process Development Engineer (Assembly) will be responsible fordesigning, developing ...

... Director of Planning & Development is responsible for ensuring the public safety, health, and well ... Oversee building and safety inspection services, housing regulations and permit processing. Create ...

As we scale, we are looking for a Director of Business Development to lead two of our most critical ... Navigate complex, multi-stakeholder contracting processes and translate Salvo's value proposition ...

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Director Of Process Development information

What are the key skills and qualifications needed to thrive as a Director Of Process Development, and why are they important?

To thrive as a Director Of Process Development, a strong background in process engineering, project management, and a relevant advanced degree (such as in chemical engineering or biotechnology) is essential. Expertise in process simulation software, Six Sigma/Lean methodologies, and regulatory compliance systems is typically required. Leadership, strategic thinking, and effective cross-functional communication are vital soft skills for driving innovation and aligning teams. These competencies ensure successful process optimization, regulatory adherence, and achievement of organizational goals in a dynamic industry.

What does a Director of Process Development do?

A Director of Process Development oversees the design, optimization, and implementation of processes within an organization, often in manufacturing, biotechnology, or pharmaceuticals. They lead teams to improve efficiency, ensure quality standards, and drive innovation from concept to production scale. This role involves collaborating with cross-functional departments, managing budgets and timelines, and staying updated on industry trends and regulatory requirements. Their ultimate goal is to streamline operations and support the company's strategic objectives.

What is the difference between Director Of Process Development vs Process Engineer?

AspectDirector Of Process DevelopmentProcess Engineer
CredentialsBachelor's/Master's in Engineering, often with experience in process developmentBachelor's or higher in Engineering or related field
Work EnvironmentLeadership role overseeing process development teams, strategic planningHands-on technical role focusing on process design and optimization
Industry UsageCommon in manufacturing, pharmaceuticals, biotechFound across similar industries, often reporting to Directors or Managers

The main difference is that the Director Of Process Development leads and strategizes process development initiatives, while Process Engineers focus on executing technical process improvements. The director role involves higher-level planning and team management, whereas Process Engineers are more involved in technical implementation.

How does a Director of Process Development typically collaborate with cross-functional teams to drive process improvements?

A Director of Process Development regularly partners with R&D, manufacturing, quality assurance, and regulatory teams to develop and refine processes. This collaboration involves leading cross-functional meetings, aligning project goals, and ensuring that new or improved processes meet both technical and compliance standards. Effective communication and project management skills are essential, as the director often serves as a bridge between technical staff and executive leadership, ensuring that process initiatives support broader business objectives.
What are popular job titles related to Director Of Process Development jobs in Michigan? For Director Of Process Development jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Director Of Process Development jobs in Michigan look for? The top searched job categories for Director Of Process Development jobs in Michigan are:
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Full-time

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Job description

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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.