Principal Investigator - Quality Control

Position Summary:

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:

Specific responsibilities include, but are not limited to:

• 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.

Computer Skills

To perform this job successfully, an individual should have proficient knowledge of Microsoft Office 365 Suite, ERP System, and Internet browser software.

Language Skills

Ability to read and interpret documents such as federal regulations and FDA industry guidance documents, safety rules and regulations, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to stand; walk; use hands to handle or feel; and talk or hear. The employee is frequently required to reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit and taste or smell. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee could be exposed to wet and/or humid conditions; extreme cold; risk of electrical shock and highly flammable materials. The employee could be exposed to high, precarious places; fumes or airborne particles; toxic or caustic chemicals; outside weather conditions; extreme heat and vibration.

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.

Job Type: Full-time

Pay: $90,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Ability to Commute:

• Edinburgh, IN 46124 (Required)

Ability to Relocate:

• Edinburgh, IN 46124: Relocate before starting work (Required)

Work Location: In person

Salary : $90,000 - $110,000