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Director, Analytical

Location

Durham, NC, USA

Department

Research and Development

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

Our Analytical Services Department is seeking a high-level management candidate to oversee of a core-team of scientists focused on supporting a wide range of testing services for clients in late phase and commercial operations.  The person’s primary responsibilities will include overseeing and planning resourcing across  this Analytical team, delivery of project milestones, development of personnel and operational excellence initiatives within analytical.

This role will interact with clients and is responsible for successfully meeting client and departmental objectives in a timely manner.

Responsibilities

  • Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals
  • Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer
  • Manages the day to day operations for assigned area.
  • Ensures all staff members are fully trained.
  • Participates in and supports client visits, audits and inquiries to ensure complete fulfillment of requests and interests.
  • Recruits, trains, develops and retains staff for the effective process of departmental operations.
  • Provides technical guidance for troubleshooting and investigating simple to complex issues in area of expertise.
  • Applies statistical analysis for interpretation of project data.
  • Ensures all cGxP data generated for projects are managed and evaluated as described in relevant internal procedures and regulatory requirements.
  • Effectively resolves quality issues and concerns in a timely manner.
  • Actively contributes to the preparation and coordination of internal audits and regulatory inspections.
  • Creates strong and effective relationships with clients.

Qualifications

Education & Experience

Requires a life science degree with at least 8+ years of relevant Operations experience (depending on degree earned) within the Pharmaceutical Industry. Must have a minimum of 3+ years of experience in management roles directly supervising staff.

 

Required Knowledge/ Skills/Abilities

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.
  • Experience with client audits.
  • Strong understanding of basic lab techniques.
  • Strong knowledge of FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
  • If applicable, experience with compliance for API and drug product and/or drug substance.
  • Experience with regulatory agency inspections of GXP facilities.
  • Experience working with CDMOs.

Skills / Abilities:

  • Proven ability to work with site Quality and Operation teams to build and standardize quality systems across sites.
  • Excellent analytical and problem-solving skills, with the ability to think strategically.
  • Strong attention to detail, as well as time and resource management.
  • Strong 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.
  • High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
  • Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.