Job Information: Supervisor, Analytical Development Job

Why Join Societal CDMO?

Mission and Culture:

Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients lives through client partnerships. Whether you are working hands-on developing, manufacturing, or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives.

We foster a culture that is diverse, inclusive, challenging, and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization and we encourage our employees to continue their personal and professional development in a variety of ways.

Benefits:

We offer a competitive total rewards package that includes health benefits, annual performance bonus, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions and much more!

Your New Role At Societal:

The Supervisor of Analytical Development oversees the daily operations of analysts responsible for a number of infrastructure items within the Analytical Development Group, including but not limited to: participating in method validation exercises, managing the AD Stability program, handling sample management and storage, overseeing the cleaning verification testing for PD/Manufacturing equipment, data review, scheduling testing within the AD group, coordinating training of personnel, and participation in appropriate internal improvement projects. The supervisor will answer questions that arise regarding cGMP and internal requirements of a particular activity or job function. The supervisor will communicate any non-compliant activities to management without delay. The supervisor is responsible for scheduling personnel and material resources to ensure that testing commitments and project timelines are satisfied and communicating any problems or difficulties to management. The supervisor is accountable for the accuracy, integrity, and security of all results generated by the working group. The supervisor will be required to review and/or approve SOPs, analytical procedures, analysis reports, validation documents, etc. at the discretion of management. The supervisor has the authority to approve and release data packages. The supervisor may recommend job actions regarding subordinate staff to management.

How You Will Make An Impact:

Review data, protocols, and reports for method development, method validation, method transfers, and Pharm R&D support activities.
Review and approve data packages that support on-going validation efforts for submission to the Validation department.
Review and approve the results from contract labs.
Review and countersign (when necessary) logbooks, notebooks, and worksheets for compliance with written procedures and assurance of data integrity.
Identify deviations to written procedures. Write or review deviation investigation reports.
Data Archival/Data retrieval.
Serve as subject matter expert on operation and troubleshooting of select laboratory instrumentation (i.e. Empower software, Waters HPLC, Agilent Gas Chromatograph).
Trending of test results to identify potential excursions from normal operating parameters.
Assign testing based upon priorities and available resources and trained personnel.
Supervise assigned projects to ensure compliance with all applicable procedures, and timely completion.
Ensure compliance with the change control policy, and other site wide programs (i.e. documentation).
Write, revise or review SOPs, analytical protocols, analysis reports, specifications, and controlled forms.
Ensure subordinate staff is adequately trained to perform job assignments. Execute training in accordance with written procedures, once certified as a qualified trainer. This would include but is not limited to training subordinate staff, perform training assessments, document training, and assist in the preparation of training programs and curricula.
Ensure compliance with DEA regulations and internal controlled substances security and reconciliation programs.
Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation. Initiate and supervise laboratory investigations. Train analysts in the investigation process. Write or review investigation reports and other forms required by the investigation procedure.
Participates in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding subordinate staff.
Assemble and review time sheets for subordinate staff.
Identify and report unsafe conditions within the laboratory.
Supervises work of others, including planning, assigning, scheduling and reviewing work, ensuring quality standards. Is responsible for hiring, terminating, training and developing, reviewing performance and administering corrective action for staff (may be subject to final approval by leadership). Plans organizational structure, position content and staffing.


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