Senior Laboratory Manager

Job Summary

Independently and effectively Manage Department personnel, activities and initiatives related to testing and ensure achievement of goals.

Essential Duties

⦁    Manage the conduct and quality of all aspects of operations, activities, and/or projects in the department.  ⦁    Provide oversight for all departmental sample processing. Ensure that staff is provided with adequate training and that samples are processed accurately, efficiently and in compliance with GMP standards and any applicable regulatory guidelines. ⦁    Ensure on-time delivery of all client projects involving, but not limited to, protein characterization and release testing, method transfer, and assay validation.  Participate in and support cross functional communication and laboratory activities as necessary.   ⦁    May conduct technical review of study data. ⦁    Interview and select qualified non-exempt and exempt personnel.   ⦁    Monitor performance of direct reports.  Regularly provide direction, coaching and counseling.   ⦁    Provide recommendations regarding personnel actions, including hiring, promotions and raises.   ⦁    Prepare and deliver salary and performance reviews of direct reports. ⦁    Partner with Human Resources to resolve disciplinary issues.  Create appropriate personnel action paperwork. ⦁    Review and approve timecards.  Coordinate vacation/time off schedules of staff.  ⦁    Identify training and development needs of direct reports.  Develop and oversee the implementation of departmental training programs, including orientation; monitor training programs to ensure ongoing effectiveness. ⦁    Resolve complex internal and external customer requests, inquiries, and complaints and provide technical assistance through delegation to subject matter experts as needed. ⦁    Share responsibility for developing/planning new product development by participation in client visits and conference calls. ⦁    Confirm that departmental equipment is maintained in good working condition through delegation of responsibilities and duties to subordinates. ⦁    Ensure departmental area(s) are maintained in a clean and orderly condition, presenting as audit ready at all times. ⦁    Oversee the development, writing, and timely review of SOPs, Protocols, and Amendments.

Responsibilities

⦁    Recommend mid- to long-range operating objectives, organizational structure, staffing requirements and succession plans. ⦁    Collaborate with appropriate departments to coordinate performance of projects, discuss issues and prepare reports. ⦁    Determine and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices. ⦁    Serve as a model to departmental subordinates as it relates to behavioral expectations, effective time management, communication, and utilization of resources.   ⦁    Provide leadership and motivation to departmental personnel, as well as having ability to influence those in non-direct reporting relationship. ⦁    Assist in the development of short- and long-range operating objectives, organizational structure, and staffing requirements of the department.   ⦁    Assist in the development of a departmental plan for backup and succession of supervisory staff and key technical personnel. Partner with management to plan for technical growth of staff and ensure that competencies meet current and future needs. ⦁    Assist in the development and recommendation of departmental budget. Authorize expenditures in accordance with budget.  Approve budget and expenses of subordinates. ⦁    Monitor quality of supporting services to the department such that projects are completed accurately and timely. Provide the primary point of contact for such support group communication (lab-wide, site-wide, or company-wide).  ⦁    Serve as the department’s lead contact person for internal QAU issues. Ensure compliance, follow through, and work to resolve issues that directly impact compliance. ⦁    Act as the primary contact, prepare for and participate in customer audits. Respond to audit findings in a timely fashion. Initiate corrective action, provide support and follow through on findings and action items to ensure adherence to protocols, SOPs, etc. Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols]. ⦁    Ensure staff training records are maintained and audit ready through delegation to subordinates. ⦁    Support the policy of equal employment opportunity through affirmative action in personnel actions. ⦁    Have a strong understanding of cGMP as they apply within the department operations. ⦁    Perform all other related duties as required.

Job Qualifications

⦁    Education: Master’s degree or equivalent in Chemistry/Biotechnology or related scientific discipline.  ⦁    Experience: Minimum of 5 or more years of relevant laboratory/GMP experience, two or more years as a laboratory supervisor.  ⦁    An equivalent combination of education and experience with contract research or the pharmaceutical industry may be accepted as a satisfactory substitute for the specific education and experience listed above. ⦁    Certification/Licensure: None. ⦁    Other: Demonstrated leadership skills and knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is required. Position also requires familiarity with general bioanalytical assays involving, but not limited to, USP methodology, HPLC,CE, MALDI-TOF MS, IEF, ELISA, SDS-PAGE and protein sequencing. Exercises judgment within defined procedures and practices to determine appropriate action.  Ability to collaborate effectively within a group environment. Able to communicate (verbal and written) effectively in a small group or one on one setting.  Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software. Ability to understand and use internal software programs such as LIMS required.

PHYSICAL DEMANDS: ⦁    Must be able to remain in a stationary position 50% of the time while performing laboratory tasks. ⦁    Regularly observes, inspects, and interprets laboratory experiments, requiring close vision and the ability to adjust focus and detect and differentiate colors.  ⦁    Frequently required to walk, sit, stand, reach with hands and arms, and use hands to finger, handle, or feel objects, tools, or controls. ⦁    Regularly lift and/or move up to 10 pounds and may occasionally lift and/or move up to 50 pounds.  ⦁    Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.  ⦁    Must regularly communicate with employees; must be able to exchange accurate information. 

WORK ENVIRONMENT: ⦁    General laboratory working conditions. ⦁    General office working conditions. ⦁    The noise level in the work environment is usually low - moderate.

Compensation Data

The pay range for this position is $120,000 to $140,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

Competencies