Manager, Analytical Services

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.