Array BioPharma Analytical Development & Quality Control Manager in Boulder, Colorado

Company:

Array BioPharma is a biopharmaceutical company headquartered in Boulder, Colorado, with locations in Cambridge, MA and Morrisville, NC. Array is focused on the discovery, development, and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. We are a fully integrated, commercial biopharmaceutical company and received our first approval in late June.

Summary:

Residing in our Boulder, CO office, this position provides support and oversight of Analytical activities focusing on the management of stability programs, standards, method development and validation to satisfy the quality and regulatory requirements for small molecule manufacturing and testing in a rapid growth environment.

Responsibilities:

  • Support multiple Array sponsored external contract analytical testing laboratories including the following activities:

  • Oversee stability program management including review and approval of data, protocols, and reports. Review trends and support setting appropriate expiry dating.

  • Oversee the management, transfer and qualification of lab reference standards and impurities at contract labs.

  • Support of analytical method transfer, development, qualification and validation for small molecule pharmaceutical products. Understands the phase appropriateness of methods and ensures compliance to these standards by the contract labs.

  • Provide input on method troubleshooting and laboratory investigations. Assists in GMP investigations, including deviation root cause analyses, CAPA, and out-of-specification.

  • Exercises sound scientific judgment in selecting methods, techniques, and evaluation criteria for obtaining results for use at contract laboratories.

  • Follows Standard Operating Procedures (SOPs), protocols and other instructions from management.

  • Draft or review organizational appropriate SOPs.

  • Takes ownership of Array stability programs including all change request activities.

  • Owns the standards management program including maintaining sufficient inventory levels and transfer of materials across multiple vendors.

  • Effectively uses the Array document management system including the change control module.

  • Support strategic analytical initiatives in the Supply Chain and Manufacturing organization.

  • Supports process development, specification setting, and CMC regulatory filings and responses as applicable.

  • Support both release and stability testing of drug substances and drug products as required.

Requirements:

  • BS/BA in Chemistry or related fields with 10 years related experience or, PhD with 5 years related experience

  • Technically proficient in analytical methodology including HPLC, LC/MS, GC/MS, dissolution, wet chemistry, physical characterization, etc.

  • Knowledge of regulatory guidelines and industry standards, including cGMP requirements, ICH guidelines and understanding of regulatory requirements and trends related to analytics and product development

  • Experience managing external analytical testing laboratories including stabilities and method transfers

  • Experience with early and late stage small molecule pharmaceutical development desired

  • Excellent interpersonal skills, organizational skills and communication skills

  • Ability to operate in a fast-paced, multi-disciplinary industrial environment

  • Excellent strategic and analytical thinking, and problem solving

  • Highly collaborative; ability to work well with teams and internal/ external customers; excellent written and oral communication skills

  • Ability to author protocols and reports for stabilities and specification justification

  • Business travel required up to 10%

Requirements:

  • BS/BA in Chemistry or related fields with 10 years related experience or, PhD with 5 years related experience

  • Technically proficient in analytical methodology including HPLC, LC/MS, GC/MS, dissolution, wet chemistry, physical characterization, etc.

  • Knowledge of regulatory guidelines and industry standards, including cGMP requirements, ICH guidelines and understanding of regulatory requirements and trends related to analytics and product development

  • Experience managing external analytical testing laboratories including stabilities and method transfers

  • Experience with early and late stage small molecule pharmaceutical development desired

  • Excellent interpersonal skills, organizational skills and communication skills

  • Ability to operate in a fast-paced, multi-disciplinary industrial environment

  • Excellent strategic and analytical thinking, and problem solving

  • Highly collaborative; ability to work well with teams and internal/ external customers; excellent written and oral communication skills

  • Ability to author protocols and reports for stabilities and specification justification

  • Business travel required up to 10%