Process Development Scientist

PPL Pharma Solutions Riverview LLC; Riverview (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Solutions in Riverview, Michigan seeks a Process Development Scientist to drive the development and optimization of synthetic pathways and oversee analytical testing (HPLC, NMR, XRPD, GC-HS).

You will manage scale-up purification and lyophilization of intermediates and final products, ensure cGMP documentation, and maintain clear client communications while supporting HP/API production transfers.

Qualifications

• PhD/MS/BS in Organic or Medicinal Chemistry with relevant field experience.
• Strong knowledge of organic chemistry and chemical safety.
• Ability to direct projects on high-potent APIs and communicate with clients.

Responsibilities

• Develop and manage process development of synthetic pathways with analytical testing.
• Scale-up purification and lyophilization for intermediates and final products.
• Ensure cGMP documentation and regulatory compliance.
• Maintain client communications and manage inventory and reports.
• Provide technical support to operators, engineering, and QA/QC teams.

Skills

Organic chemistry knowledge

Chemical safety

Project management

Communication skills

Education

PhD in Organic or Medicinal Chemistry

MS in Organic or Medicinal Chemistry

BS in Organic or Medicinal Chemistry

Tools

HPLC

NMR

XRPD

GC-HS

Lyophilization

Job description

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

Location

Riverview, Michigan

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.

Company Overview

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

Equal Employment Opportunity

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.