Job Details:

Sentry BioPharma Service provides clinical support, packaging and labeling, and logistics services to hundreds of biotechnology and pharmaceutical companies.  We are adding Quality Control lab services to support our customers from Phase I clinical to post registration. Our clients work across all therapeutic classes/ modalities allowing for rapid career growth of the principal investigators and the lab staff. The Principal Investigator will serve as the lead scientists on assay development, assay validation and sample analysis studies. This individual will help train and mentor the quality control chemist/analyst. The ideal candidate should be able to communicate at all levels of the organization and be highly motivated and self-driven.

Essential Duties & Responsibilities:

  • Assist Quality Control Director in the development and implementation of the Quality Control Laboratory and site-specific Quality Management Systems (QMS) to meet cGMP requirements including SOPs and client-specific procedures.
  • Write validation protocol and reports.
  • Assist analyst in trouble shooting assays.
  • Responsible for assisting in the creation of instrumentation SOPs and validation protocols/reports.
  • Responsible for the conduct of study including the prompt creation and review of deviations
  • Contribute the management and validation of the LIMS and ELN systems.
  • Assistant business development as the SME on new programs.
  • Oversee and direct the implementation and operation of the Quality Control laboratory systems.
  • Communicate with clients about timelines, scheduling and data summaries.
  • Participate in and provide support for on-site regulatory for laboratory operations including Client and third-party audits of this area.
  • Write SOPs and related forms.
  • Maintain a working knowledge of applicable laws, regulations, and cGMP/GLP requirements.
  • Direct initiatives that accomplish continuous improvement, cost effectiveness, new capabilities, and enhanced efficiencies of laboratory operations while maintaining compliance of processes and procedures.
  • Communicate to Management any critical cGMP and/or non-compliance issues in a timely manner.
  • Other duties and responsibilities as assigned.

Qualifications:

  • Embraces change and is dedicated to continuous improvement. Consistently searching for more efficient and effective ways to improve processes and procedures.
  • Excellent communication skills with all levels of the organization and ability to develop rapport with other functional leaders within the Group to make decisions.
  • Drives results through team leadership. This would include working with the team/individual to define specific goals and progress measuring tools.
  • Strong problem solving, solutions orientation and presentation skills.

Education and/or experience

  • BS or BA degree in life sciences, physical sciences, engineering, or related discipline.  7 years or more of quality control laboratory experience in pharmaceutical, medical device, or other related industries or an equivalent combination of education and experience. Ph.D. must have 5 years of experience in the CMC/GMP space.
  • In-depth knowledge of regulatory requirements for laboratory and pharmaceutical manufacturing operations including Title 21 CFR § 211 requirements, ICH guidelines, FDA cGMP/GLP regulations, and on EU Regulations.
  • Proven ability to work cross-functionally to achieve business outcomes.
  • Experience in auditing/inspecting, data and document review, internal and external inspection.
  • Ability to develop assays based on HPLC, LC-MS, and or LBA formats.
  • Capable of working on multiple projects simultaneously.  Must be well organized along with being detail and multi-task oriented.  Ability to meet aggressive timelines.
  • Good interpersonal/teamwork skills. Must possess and demonstrate motivational and leadership qualities. 
  • Effective communication skills (verbal and written form) to include experience in technical writing, including requirements gathering, is required.

Other Skills and Abilities

  • Able to maintain regular and predictable attendance.
  • Able to establish and maintain effective relationships with those contacted within the line of work.
  • Needs to be prepared for international travel as needed.

 

Location: Columbus, IN

Department: Quality Assurance

Schedule: Full Time, On-Site

Education: BS or BA in life sciences, physical sciences, or engineering (Required) 

Experience: 5 Years in CMC/GMP space