Manager, QC Analytical Development

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

To support our rapid growth, we are seeking a highly talented and motivated Manager, Quality Control (QC) Analytical Development to join our organization. The Manager, QC Analytical Development will be responsible for the oversight and management of all day-to-day activities in support of the Analytical Research and Development programs. This role will require a high level of customer service, collaboration and cross functional support for quality control and manufacturing operations at our Harvey Road, Bedford, NH, Commerce Drive, Bedford, NH, Madison, Wisconsin and San Diego, CA Facilities, including interactions with external customers. The ideal candidate will be an innovative leader with experience in Analytical Development and Quality Control environments.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Actively partners with Project management, Operations, Quality Control and Quality Assurance to ensure completion of activities within required timelines are met.

Manages a team of 8-10 direct reports ranging from QC Analytical Development Scientist II through Senior Scientists.

Perform continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies.

Responsible for developing and implementing analytical development strategies to achieve optimal results.

Identifies analytical science capabilities and technology tools needed to enable method development, QC testing, and new drug introduction/support.

Applies scientifically driven thinking to the development of scientifically sound, well understood, and phase appropriate analytical methods for development compounds, raw materials, intermediates, drug substances and drug product.

Manages analytical activities for method development, validation and transfer.

Reviews, prepares and delivers technical documents for method introduction and transfer to Quality Control Analytical Lab.

Discusses laboratory method qualifications in detail with clients using guidelines as established through the ICH as well as USP.

Participates in weekly client calls as the Analytical Development representative.

Special 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

Work Environment:

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.

Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs.

Capacity to work on several tasks simultaneously.

Able to organize and prioritize work activities.

Must be able to walk and drive between locations.

Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.

Comfortable with working/handling of hazardous materials

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor's degree in chemistry/Biochemistry with 10-15 years' experience or master's degree in analytical chemistry or equivalent with 7+ years' experience

10+ years of relevant working experience in Quality Control or Analytical Development in pharmaceutical industry. Being skilled in the application of cGLP/cGMP is desirable; 2+ years of management/leadership responsibilities.

Extensive analytical development background with working knowledge of chemistry, analytical or pharmaceutical science and QC experience.

Proficiency with performing analytical testing using the following types of equipment, but not limited to: HPLC/UPLC, GC, FTIR, UV/VIS, Karl Fisher, Particle Size Analyzer, Osmometer, pH is required.

Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.

Have both broad and in-depth knowledge as well as hands-on experience in modern analytical chemistry techniques including outstanding problem-solving abilities.

Experience working in a CDMO environment is preferred.

Manages and develops 8-10 direct reports ranging from QC Analytical Development Scientist II through Senior Scientists.

Interacts with all departmental staff to coordinate activities.

Works with project management to determine timelines for QC Analytical Development activities.

Interacts with upper management in regard to any delays in timelines or obstacles in the way of completion of QC activities.

Assigns responsibilities and duties within the group.

Provides constructive feedback to team and authors performance reviews within corporate timelines.

Advanced interpersonal skills with ability to influence team.

Excellent communication skills both oral and written.

Demonstrated advanced capability for multi-tasking in a dynamic environment with changing priorities.

Highly resilient can quickly move forward despite challenges.

Maintains a positive outlook, able to work in a highly collaborative environment while balancing independent thinking.

Honesty, integrity, respect and courtesy with leadership and peers

Strong commitment to conducting PCI Pharma business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI pharma products and services.

A thirst for knowledge, expected to stay informed of industry advances and bring those ideas to the team.

Possesses superior attention to detail as well as the ability to work in a cross-functional team environment.

Excellent organizational skills and the ability to work within a fast-paced environment.

Multi-disciplinary knowledge of Quality Control Analytical Development and instrumentation associated with the testing.

Exemplary capability for logical, analytical, and strategic thinking

Problem analysis and resolution skills required.

Experience working in a laboratory under cGMP, ICH, USP, and global compendial regulation.