Manager, Chemistry Operations

Role Overview

• Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to Chemistry testing of product assuring that products are manufactured in compliance with cGMP guidelines, USP and FDA, EU requirements.
• Assure that any discrepancies are investigated thoroughly and in a timely manner.
• Manager the data review of all testing, lab notebooks and empower.
• Responsible for managing people and systems that assure product quality.
• Ensure that non-compliant situations are thoroughly investigated.
• Organize, direct and evaluate the routine activities of the Chemistry Laboratory to ensure the safety and reliability of products, and to comply with quality and regulatory requirements.
• Identify potential risks associated with laboratory operations and lead teams to resolve lab issues.
• Oversee Quality Lab Training Program.
• Manage Laboratory investigations to ensure the laboratory investigation for OOS/OOT or for any known analytical error concluded with appropriate Root Cause and CAPA.
• Ensures Laboratory is clean, organized, compliant and audit ready at all the time.
• Ensure compliance of laboratory personal and equipment.
• Responsible for all data review to ensure testing is completed per current test methods and SOPs, ensure data integrity and Good Documentation Practices.
• Responsible for performing regulatory gap assessment when a new regulation is released, or existing regulation is updated.
• Manage method verifications and validation studies in support of compendial changes, regulatory compliance and new product support.
• Review and approve study protocols and reports.
• Manage CPA's and operating budget for the lab.
• Work with teams of business units and meeting operational goals.
• Provide directions to team using Quality Laboratory short-term objectives, general policies and management guidance related to lab operation.
• Ensure compliance with testing SOPs and specifications.
• Monitor the testing techniques and accuracy of all records and documentation that is done in the lab.
• Ensure Analytical methods are in compliant with USP updates.
• Oversee method verification/validation due to qualification of new API source.
• Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
• Manage capital and operating budget for the lab.
• Assure compliance with company procedures.
• Prepare the department ready for an audit by both internal and external authorities.
• Assure employees are properly trained and audited.
• Make appropriate staffing recommendations.
• Evaluate performance via performance appraisals and insure employees have development plans.
• Conduct routine investigation and departmental meetings to facilitate the performance of release function.
• Places lots on HOLD if Quality issues are detected and notify senior management.
• Attend interdepartmental meetings representing Chemistry and makes sound quality decisions.
• Manage attendance records for all direct reports.

Requirements

• Requires a bachelor’s degree in chemistry or closely related field and at least 7 years of pharmaceutical laboratory experience, or a master’s degree in chemistry or closely related field with 5 years of pharmaceutical or related laboratory experience, or a Ph.D. in chemistry or pharmaceutical science or closely related field and 3 years of pharmaceutical or related laboratory experience.
• Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs very well.
• Thorough understanding and proficiency in the use of Empower Software and LABWARE LIMS.
• In-depth knowledge of lab techniques.
• Proficiency in the use of Microsoft Office including Word and Excel.
• Project planning techniques and use of project planning software, a plus.
• Excellent communication skills, both oral and written.
• Capable of maintaining professional demeanor under stress.
• Must have the ability of managing complex projects and resolving complex lab issues.
• Must possess excellent supervisory and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
• Must have history of strong documentation skills and attention to detail.
• Familiarity with cGMPs and CFR for US and EU.
• Excellent organizational skills and ability to multi-task and perform work in a timely manner.
• Demonstrates ability to lead a department, projects and meetings effectively.
• Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management.
• General computer skills and ability to prepare presentations and address large groups.
• Demonstrated attention to details and accuracy.

Benefits

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.
• Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).
• Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave