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Associate Manager, Bio Pharma

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 motivated biopharmaceutical management candidate to oversee a rapidly growing projects-oriented core-team of analytical scientists focused on supporting a wide range of drug substance and drug product testing services for biotherapeutic clients in clinical and commercial operations. This role is focused in large molecule and viral biopharmaceutical development and testing services.  The person’s primary responsibilities will include overseeing and planning resourcing across this Analytical team, delivery of project milestones, collaborations between analytical core teams, 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

  • Lead a projects-oriented core-team of highly cross-trained biopharmaceutical scientists supporting method development and testing services in several biopharmaceutical service offerings
  • Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals
  • Supports creations of departmental systems and fosters a culture of continuous improvement focused on value to the customer
  • Supports team to ensure proper creation of test methods, validation protocols, validation reports, stability protocols and reports, and development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis for infectious titer, host cell DNA, Host cell protein, ELISAs, particulate analysis, aggregation, purity and potency, etc.
  • 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 fulfilment of requests and interests.
  • Supports Recruitment, 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.
  • Creates strong and effective relationships with clients.

 

Qualifications

  • A PhD with management experience is preferred with a focus in Biochemistry, Microbiology, Biology or another relevant area however strong candidates with Bachelors or Masters degrees will also be considered.
  • Requires an advanced life science degree with at least 5+ years of relevant Operations experience (depending on degree earned) within the Pharmaceutical Industry. Must have a minimum of 2 years of experience in management roles directly supervising staff in Biopharmaceutical development and testing workflows.
  • 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.
  • Excellent analytical and problem-solving skills, with the ability to think strategically.
  • Strong understanding of applicable GMP/ICH requirements
  • Passionate about technical expertise and quality work while remaining an inclusive team member
  • Preference to those that demonstrate a winning attitude, drive, great organizational skills, and attention to detail
  • 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.
  • Flexible mindset to be able to learn and troubleshoot new techniques
  • Must be able to schedule time and be organized
  • Must have strong operational knowledge of molecular biology and/or cell culture techniques
  • Use of a variety of biopharmaceutical instrument software including: SoftMax Pro (Plate reader), Quant Studio 5 (qPCR), MiSeq (NGS), Image Lab Secure (Bio-RAD ChemiDoc MP), Empower, Mass Hunter
  • Ability to handle multiple priorities and projects concurrently
  • Demonstrated accountability with prior positions
  • Ability to adhere to a strict attendance policy
  • Excellent verbal and written communication and analytical skill with a strong attention to detail

 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

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