Senior Scientist

Job Description:

The Product Development (PD) Senior Scientist I, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach. The incumbent plans, coordinates and executes current Good Manufacturing Practices (cGMPs) pilot and pivotal/submission batches, including all required documentation. She/he prepares technical and product development reports and regulatory submission document and performs critical analysis.

• Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws

• Designs, plans and conducts product development activities, including pre-formulation, formulation, process development and scale up studies of complex projects to ensure good scientific standards are met

• Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (cGDP) and cGMP; Summarizes data, discusses results and makes conclusions in technical reports; Meets project deadlines and performance standards, as assigned

• Creates invention disclosures; Collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications, and respond to office actions

• Utilizes risk-based approaches and Quality by Design (QbD) principles in guiding pharmaceutical development and identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) and control strategies. Uses problem solving tools to trouble shoot, as needed

• Designs and conducts physical and chemical characterization in liaison with analytical teams

• Performs critical data analysis using statistical tools including stability analysis

• Plans, coordinates and manufactures cGMP pilot and pivotal batches, including drafting of protocols, master batch records and reports

• Liaises, coordinates and manages PD activities with external labs, Clinical Research Organizations (CROs) and Clinical Development Manufacturing Organizations (CDMOs), including cGMP manufacturing activities; Collaborates closely with other functions within and outside R&D to ensure project timelines are met

• Presents and updates project status and issues/challenges to management

• Supports technical services and operations to trouble-shoot scale up and commercial processes

• Collaborates with, and assists, Regulatory Affairs with coordination and submission of pivotal batches to CROs

• Ensures cleanliness and functioning of PD areas and proper maintenance of equipment and instruments; Supports review of qualification documents for process equipment

• Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports

• Creates and revises PD Standard Operating Procedures (SOPs), as needed

• Collaborates with Quality Assurance (QA) department on investigations, Corrective Action Preventive Action (CAPAs) and changes controls, as needed; Supports Technical Services and Operations departments to troubleshoot scale up and commercial processes

• Participates in training of new employees and mentors lower level scientists

Job Skills & Qualifications:

Bachelors degree in Pharmaceutical Science or related scientific field and minimum 10 years experience in pharmaceutical formulation and product development OR

Masters degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development. OR

PhD in Pharmaceutical Science or related scientific field and minimum 3 years experience in pharmaceutical formulation and product development

• In depth experience designing and conducting oral controlled release solids and liquids pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms

Working knowledge of QbD and risk-based approaches

• Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines

• Strong technical writing skills and experience (i.e., SOPs, investigations, protocols, reports, submission documents, etc.)

• Proficiency with Microsoft Office

• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members

• Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines

• Planning, organization and time management skills including the ability to support and prioritize multiple projects

• Fluent in English (verbal and written)

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $115,000 - $130,000