Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview Our Analytical Services Department is seeking a motivated analytical scientist at the Manager level to oversee a growing team of analytical scientists focused on supporting a wide range of clinical to commercial Quality Control and Analytical Development workflows for drug substance and drug product. Reporting to the Associate Director, the Analytical Services Manager will provide overall strategic oversight and operational direction for a highly cross-trained team of analytical scientists simultaneously supporting both development and quality control testing for small molecule drug substances and drug products in a fast-paced work environment. The Manager will be responsible for operational project planning including resource allocation, technical project oversight, quality oversight, and business level management to support ongoing or incoming projects. This role will interact with clients and is responsible for successfully meeting client and departmental objectives in a timely manner. The Manager will have direct responsibility over laboratory and non-laboratory(technical review) support staff. QuantitativeLCMSMS Experience Required Responsibilities An SME in more than one functional area with ability to drive client program success through team leadership across areas of support. Overseeing and coordinating the daily prioritization of the laboratory functions for GMP and non-GMP projects, including scheduling of assigned staff and equipment and lab productivity assessments Strong ability to develop and validate analytical methods, and rapidly troubleshoot issues that arise during analytical development Direct supervision of laboratory staff in the functional area and non-laboratory staff (technical reviewer(s)). Providing feedback and evaluations as needed and required. Supports team to ensure proper creation of test methods, validation reports, stability protocols and reports, and development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by HPLC/UPLC (PDA/VWD/CAD/ELSD/RID/FLD/MSD), FT-IR, GC-FID/MS, cKF, ROI, Dissolution, etc. Ability to identify and or hire top talent and foster talent growth within the team. Must be capable of providing backup assistance in performing testing and reviewing laboratory data included but not limited to, HPLC, GC, IC, FT-IR, KF, and dissolution. Provide scientific and quality oversight with ability to troubleshoot instruments. Work cross-functionally with other departments and teams as a required. Drives continuous improvement in quality and technical culture within team. Provides regular detailed updates to clients on project deliverables, with increasing responsibility to represent the sites quality and technical culture to clients. Assisting with management of critical laboratory programs such as stability and reference standard programs Qualifications/Skills Essential Job Requirements • 2+ years of previous management experience in a quality laboratory environment required. • Strong analytical chemistry knowledge with ability to assess CQA gaps in DS and DP control strategies • cGMP knowledge with experience in RCA • Strong familiarity with instrument operation and troubleshooting • Participates in and supports Lean 6S principles and implementation of Lean Labs • Must be able to identify discrepancies, author out of specification and deviation investigations, and support CAPAs within functional area. • Experience supporting manufacturing operations is highly beneficial. Required Knowledge/ Skills/Abilities Knowledge Knowledge: • Strong technical skills for area managing • Good business acumen • Strong understanding of company SOPs, and regulatory guidance documents. • Strong knowledge of safety procedures and quality compliance for assigned area • Strong knowledge of cGMP requirements. • Strong understanding of advanced lab techniques • Good understanding of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry. Skills / Abilities: • Excellent analytical and problem-solving skills, with the ability to think strategically. • Experience implementing phase-appropriate analytical decision making with ability to navigate method lifecycle enhancements • Understanding of applicable GMP/ICH requirements • Passionate about quality of work while remaining an inclusive team member, and technical driver • Preference to those that demonstrate a winning attitude, cultural driver, great organizational skills, and attention to detail. • Good time and resource management skills. • Personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction. • Promote a safe environment for work. • Comply with the general policy of the company. • Ability to grow and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations. Education, Experience & Licensing Requirements BS, MS, or PhD in Chemistry or related scientific field. • 2+ years of direct management experience • A minimum of 12 years (BS), 10 years (MS), or 4 years (PhD) of experience within a quality control testing environment is required. Experience in analytical development, validations, and method transfers is required. Supervision Received: General Supervision Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope. Travel: 5 – 10% 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 may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. Environment and Protective Equipment: 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 may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. An SME in more than one functional area with ability to drive client program success through team leadership across areas of support. Overseeing and coordinating the daily prioritization of the laboratory functions for GMP and non-GMP projects, including scheduling of assigned staff and equipment and lab productivity assessments Strong ability to develop and validate analytical methods, and rapidly troubleshoot issues that arise during analytical development Direct supervision of laboratory staff in the functional area and non-laboratory staff (technical reviewer(s)). Providing feedback and evaluations as needed and required. Supports team to ensure proper creation of test methods, validation reports, stability protocols and reports, and development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity, and impurities by HPLC/UPLC (PDA/VWD/CAD/ELSD/RID/FLD/MSD), FT-IR, GC-FID/MS, cKF, ROI, Dissolution, etc. Ability to identify and or hire top talent and foster talent growth within the team. Must be capable of providing backup assistance in performing testing and reviewing laboratory data included but not limited to, HPLC, GC, IC, FT-IR, KF, and dissolution. Provide scientific and quality oversight with ability to troubleshoot instruments. Work cross-functionally with other departments and teams as a required. Drives continuous improvement in quality and technical culture within team. Provides regular detailed updates to clients on project deliverables, with increasing responsibility to represent the sites quality and technical culture to clients. Assisting with management of critical laboratory programs such as stability and reference standard programs BS, MS, or PhD in Chemistry or related scientific field. • 2+ years of direct management experience • A minimum of 12 years (BS), 10 years (MS), or 4 years (PhD) of experience within a quality control testing environment is required. Experience in analytical development, validations, and method transfers is required.
