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Senior Manager, Analytical Laboratory

Blue Ash, Ohio
General Purpose of Position:
This position has responsibility for all laboratory testing at Aprecia whether performed internally or externally by a contract lab.
  • Lead the Analytical Laboratory with responsibilities including management of analytical personnel work assignments, performance of analytical testing for GMP and non-GMP purposes and maintain compliance with established procedures and cGMP regulations.
  • Work directly with the contract laboratories that perform laboratory services for Aprecia to ensure that methods are validated/verified as appropriate prior to use. Serve as the technical liaison during routine testing to address issues that may arise. Direct out-of-specification investigations and review the corresponding reports. Assist with routine audits and for cause laboratory visits as required. Perform QC review and approval of specifications, protocols, and reports.
  • Serve as the Analytical Department lead in the development, execution, transfer, and qualification of analytical methods that are necessary to support new product development, process development, and characterization and/or stability testing.  Develop and implement strategic laboratory initiatives with the objective of consistently developing robust analytical methods and techniques aligned with current FDA /regulatory expectations.
  • Provide support to Blue Ash QA as needed.
 
Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Manage the Aprecia Analytical Laboratory providing oversight for all GMP and non-GMP testing.  Serve as the primary liaison with contract laboratories that perform testing for Aprecia, ensuring that methods are suitable for use and that technical challenges are overcome.
2 Ensure that all laboratory records and technical data are accurately maintained and results well documented
3 Collaborate and work effectively within the Analytical Laboratory Department, as well as other departments (e.g., Regulatory, Quality Assurance, Manufacturing, and Business Development) across the company
4 Foster smooth functions of the Analytical Laboratory through timely and effective resolution of technical challenges. Provide GMP testing for commercial product release and stability testing as well as support to the Product Development team
5 Represent the Analytical Laboratory Department functions on projects and document reviews
6 Provide support of new product registration initiatives
7 Ensure that the Analytical Laboratory team continues to grow technically and professionally; encourage their development efforts towards excellence
8 Ensure that all required laboratory documentation is reviewed, filed and organized and when applicable, in the document archive area, including site training documentation.
9 Provide support to Blue Ash QA as needed for laboratory investigations
10 Ensure a safe laboratory environment at all the times
 
Reporting to this Position:
Principal Analytical Development Scientist(s) & Analytical Development Scientist(s)
 
Travel:
This position may require 10-15% travel
 
Work Shift:
This position works days
 
Knowledge, Skills and Abilities:
  • Thorough knowledge of GLP (good laboratory practices), GMP (good manufacturing practices), USP and related ICH (International Conference for Harmonization)/FDA guidance documents is required
  • Excellent oral and written communication, interpersonal, teamwork, and organizational skills
  • Experienced with current analytical techniques (e.g., separation technology, spectroscopy, wet chemistry, dissolution testing, etc.)
  • Excellent analytical documentation practices
  • Strong computer, scientific, and organizational skills
  • Ability to lead a team of analytical scientists, participate on cross-functional teams representing the Analytical Laboratory Department and manage time effectively in a fast-paced, goal-oriented environment
  • Ability to objectively assess laboratory results and make evidence-based recommendations on testing and other laboratory operations
  • Self- motivated person who possesses ability to motivate, train, and mentor the laboratory personnel by establishing and maintaining guidelines for standards of performance
  • Strong problem-solving and method troubleshooting skills required.
  • Excellent leadership skills required
Education and Experience:
  • M.S./Ph.D. degree in Chemistry, Biology, Biochemistry, or other related discipline or equivalent, directly related job experience preferred
  • Eight or more years of analytical development and quality control experience in cGMP pharmaceutical industry and managing laboratory personnel desired
  • In the case of highly skilled and experienced individual, a B.S with 15 years of experience may be considered with a track record of achievement.
  • Demonstrated track record and skill/experience gained from similar position(s) at a similar level is a plus
  • Experience dealing with regulatory agencies and FDA laboratory inspections is preferred
  • Experience setting up an analytical laboratory and qualifying lab equipment is preferred.
Physical Demands and Work Environment:
  • Ability to stand for extended periods of time performing laboratory testing and other operations
  • Ability to sit for extended periods of time to document and analyze test results
  • Occasional odd-body positioning (including kneeling, twisting, and bending) to manipulate and use laboratory equipment
  • Good manual dexterity to operate computer, general office, and laboratory equipment and to document laboratory testing results
  • Fine motor skills to manage more delicate laboratory testing
  • Good eyesight to read technical and instructional materials
  • Ability to lift solutions and solids weighing up to 20 pounds
  • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to laboratory and pharmaceutical operations (i.e., PAPR, over gowning, gloves, safety glasses, lab coat, steel toe shoes, etc.)
 
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.

 We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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