POSITION SUMMARY:

The Principal Manufacturing Chemist will be responsible for overseeing and participating in the technical transfer and execution of GMP and non-GMP manufacturing of intermediate and drug substance API. This position is responsible for writing and reviewing batch records, reviewing SOPs and quality documents associated with manufacturing, and maintaining a safe working environment. This position is expected to delegate tasks to junior staff and perform other supervisory tasks and oversee day-to-day operations and personnel as directed by DSDM Manager or Director.
Responsibilities:

Key Job Responsibilities:

• Draft non-GMP and GMP batch records from process description using template, as needed. Review batch records written by other Manufacturing Chemists and review executed batch records.
• Scale up and order materials for non-GMP and GMP manufacturing operations as needed.
• Assess process fit and identify appropriate manufacturing equipment. Suggest operational changes as appropriate.
• Identify and understand process safety hazards and applicable mitigation strategies. Collaborate with Process Chemistry Development and EHS to address safety risks identified during process review. Helps drive safety culture in Manufacturing group.
• Complete lab-scale front runs using GMP materials as needed.
• On the floor support and/or oversight of drug substance manufacturing operations in coordination with DSDM manager.
• Support a Quality culture within the department by setting the right example, providing training as needed and maintain accountability throughout DSDM GMP operations.
• Consistently, clearly, and accurately document activities for production records and manufacturing equipment in accordance with ALCOA, cGMP, and Good Documentation Practices (GDP).
• Write change controls and deviation responses for minor, major, and critical deviation investigations.
• Write CAPAs, complete Root Cause Analyses and risk assessments.
• Write new SOPs and revise current SOPs as necessary.
• Assist in proposal writing.

Qualifications / Skills::

REQUIRED KNOWLEDGE/ SKILLS/ABILITIES

• Lead development of project plan with minimal management review. Lead group collaborations and has advanced process and manufacturing knowledge.
• Ability to troubleshoot and resolve advanced manufacturing issues and quality events.
• Thorough understanding of cGMP and GDP requirements for drug substance manufacturing.
• Strong knowledge of manufacturing equipment operations including batch reactors, filters, dryers, pumps and glass lab equipment. Able to train others on set up and operation of any Manufacturing equipment.
• Identify and communicate schedule changes for suite operations, cleaning verifications and materials management.
• Effectively communicates both verbally and in writing with internal and external team members.
• Capable of managing 2 or more projects in parallel when needed.
• Skills in Synthetic/Organic Chemistry and Math
• Read and understand routine analytical data such as HPLC, GC, ROI, KF, and NMR data.
• Identifies chemical hazards from SDS and process risks from safety evaluation and trains others on safe operating procedures.
• Ability to wear respirators and various types of PPE while promoting a safe work environment. Holds peers and junior staff accountable for proper PPE use.
• Safely works with and supports manufacturing planning and execution of potent, highly toxic and flammable substances including training, waste handling, PPE identification.
  Qualifications:

EDUCATION & EXPERIENCE

• HS diploma with 17+ years of relevant pharmaceutical drug substance API manufacturing experience, OR
• BS in Chemistry or related field with 13+ years of relevant pharmaceutical drug substance API manufacturing experience, OR
• MS in Chemistry or related field and 11+ years of relevant pharmaceutical drug substance API manufacturing experience, OR
• PhD in Chemistry or related field and 6+ years of relevant pharmaceutical drug substance API manufacturing experience

• Draft non-GMP and GMP batch records from process description using template, as needed. Review batch records written by other Manufacturing Chemists and review executed batch records.
• Scale up and order materials for non-GMP and GMP manufacturing operations as needed.
• Assess process fit and identify appropriate manufacturing equipment. Suggest operational changes as appropriate.
• Identify and understand process safety hazards and applicable mitigation strategies. Collaborate with Process Chemistry Development and EHS to address safety risks identified during process review. Helps drive safety culture in Manufacturing group.
• Complete lab-scale front runs using GMP materials as needed.
• On the floor support and/or oversight of drug substance manufacturing operations in coordination with DSDM manager.
• Support a Quality culture within the department by setting the right example, providing training as needed and maintain accountability throughout DSDM GMP operations.
• Consistently, clearly, and accurately document activities for production records and manufacturing equipment in accordance with ALCOA, cGMP, and Good Documentation Practices (GDP).
• Write change controls and deviation responses for minor, major, and critical deviation investigations.
• Write CAPAs, complete Root Cause Analyses and risk assessments.
• Write new SOPs and revise current SOPs as necessary.
• Assist in proposal writing