This position (Scientist/Sr. Scientist, Formulation & Process Design) works within the Product Development team to design drug product formulations & manufacturing processes. This will be achieved by developing a thorough understanding of operating and performance parameters impact on quality attributes throughout the development life cycle. Has overall responsibility for supervision of outsourced manufacturing operations at CMO partner sites as Person-in-Plant (PiP)
Essential Functions and Responsibilities (including, but not limited to)
- Design & execute experiments employing quality by design (QbD) principles to develop robust formulations and manufacturing processes.
- Utilize statistical software to design and analyze Design of Experiments (DoE)
- Perform scale-up development and optimization of manufacturing processes for pharmaceutical products such as immediate release or extended release solid oral dosage forms based on current regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10).
- Collaborate with Formulation & Process Design team regarding the design and execution of pilot and commercial manufacturing operations. This can include the creation of formulation sheets, master batch records, setting process parameters, batch execution, and post batch evaluation and analysis.
- Provide technical assistance to manufacturing and quality operations for process troubleshooting.
- Review batch records, incident investigation reports, change controls, market complaints, annual product review, product development protocols and reports, drug master files, validation documents, equipment qualification reports, technology transfer dossiers, stability data, raw material data trend, CAPAs, in-process and finished product analytical data for understanding the process knowledge and identify the risks to the quality of the product.
- Ensures compliance with all aspects of cGMP’s.
- Support Formulation & Process Design efforts, QbD, Scale up, Technical Service, Cleaning Validation, Process Validation, and Stability activities as mandated by cGMP’s policies/procedures and quality standards.
- Evaluate retrospective quality by design (QbD) assessments of currently marketed products to improve quality, efficiency and mitigate potential cGMP and quality risk.
- Thorough knowledge of pharmaceutical technology and pharmacy, chemistry and/or chemical engineering principles and applications.
- Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company.
- Excellent verbal and written communication skills with experience communicating both up and down the organization. Strong technical report writing experience is required.
- Expertise in solid oral dosage form development and related manufacturing unit operations, specifically; blending, milling, wet/dry granulation, tableting, encapsulation and pan coating.
- Demonstrated and applied knowledge of pharmaceutical manufacturing equipment, especially with respect to equipment and processes used to manufacture immediate release and extended-release oral solid oral dosage forms.
- Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed during industrial process design, validation and control.
- The candidate must possess a Bachelor’s Degree (in Pharmaceutical Sciences, Chemical Engineering or Life Sciences), combined with 10+ years relevant pharmaceutical experience, or Master’s Degree (in Pharmaceutical Sciences, Chemical Engineering or Life Sciences), combined with 8+ years relevant pharmaceutical experience, or Doctorate (PhD) Degree (in Pharmaceutical Sciences, Chemical Engineering or Life Sciences), combined with 5+ years pharmaceutical experience.
- Ability/willingness to travel (domestic & international) to CMO partner sites up to 25%