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Apex Systems

Senior Scientist

Post Date:May 24, 2022Type:Full-Time
Start Date:5/3/2022Salary:
Location:US-NJ-Cranbury Job Reference:ce1cbb32ffe325a0cc9950ace04d9799
Skills:
 

Job Description:
JOB DESCRIPTION:

The Senior Scientist is responsible for the technical leadership for projects which include development, optimization and/or manufacturing processes, execution of prototype batches, generation of project documentations, coordination of raw materials and supplies, and project supervision. The Senior Scientist will work closely with the Senior Manager and Director to develop specific strategies, and support activities to meet company goals. The incumbent will support implementation for the continuous process improvement efforts within the customer's business segment in the area of technology transfer and process scale up. Assist customers in evaluating technical needs and advise on equipment selection. The individual may also participate in continuous process improvement projects and support departmental initiatives, as well as evaluate new technologies to expand our service offering. There is an expectation of direct hands-on laboratory work and/or supervision of one or more direct reports and mentoring/training of other colleagues as needed.

RESPONSIBILITIES:
  • Support implementation for the continuous process improvement efforts within the customer's business segment in the area of technology transfer and process scale up.
  • Assist customers in evaluating technical needs and advise on equipment selection.
  • Participate in continuous process improvement projects and support departmental initiatives, as well as evaluate new technologies to expand our service offering.
  • Conduct physical and chemical property assessment (solubility, stability, particle size, etc.) of candidate compounds under supervisor's direction.
  • Conduct formulation and process development for oral solid dosage forms of new chemical entities and/or generic products.
  • Perform lab and manufacturing experiment using key manufacturing equipment, including but not limited to, high shear granulator, fluid bed granulator/dryer/coater, blender, tableting machine, and film coating equipment.
  • Conduct laboratory analysis on raw materials, in-process, and product formulations using key analytical apparatus, including but not limited to, scanning electron microscope, light microscope, laser particle size analyzer.
  • Communicate results internally and externally through verbal and written updates and formal reports as necessary. Organize meetings and monitor all customer interactions independently. Participate in and lead cross-functional project teams to meet company and/or customer goals.
  • Creates and/or revises new department-wide and site-wide procedures and company SOPs.
  • Develop junior personnel in both Technical Service and Operations departments for project support.
  • Participate in new project opportunities by generating scientific expert content, hosting new customer visits or teleconferences, and attending conferences or customer visits to generate new leads.
  • Responsible for maintaining GLP/GMP laboratory environment and maintaining a safe, clean laboratory.
  • Execute laboratory work plan/schedule developed with input from supervisor or senior team member.
  • Author high quality laboratory and technical documents including protocols, batch records, study reports, specifications, SOPs, and other documents in accordance with applicable regulatory guidance.
  • Work closely with project management, operations, quality, and analytical services to lead and support formulation/process development activities.
  • Support novel manufacturing technology assessment to expand and improve CCU's technical capability according to the mid/long term investment plan.


QUALIFICATIONS:
  • Advanced degree in Pharmaceuticals, Chemistry, Chemical Engineering, or allied disciplines, Ph.D. with minimum of 2 years or Masters with minimum of 3-5 years of pharmaceutical industry experience with thorough understanding of cGMP, regulatory and safety requirements.
  • At least 2 years' experience in a pharmaceutical process/product development environment.
  • Working knowledge of the theories and manufacturing processes associated with the experimental manufacture of oral solid drug products specifically and pharmaceutical products in general.
  • Familiar with technologies including Fluid Beds, High Shear Granulators, Tablet Presses, Tablet Coaters, Blenders, Mills, etc.
  • Mechanical knowledge and hands on experience relating to fluid bed processor, granular, tablet press, encapsulation, and coating equipment.
  • Formulation and process development for oral dosage forms.
  • Technical transfer and scale up experience.
  • NDA/ANDA filing experience including design space and DOE.
  • Ability to handle difficult situations produced by time constraints and customer demands, etc.
  • Possess good knowledge of cGMP's and safety practices.
  • Possess good interpersonal skills.
  • Good verbal and written communication skills, computer skills in word processing, spreadsheets and some technical software.

For immediate consideration please submit your resume to

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice




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Apex Systems



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