Senior Scientist, Analytical Development

Replimune; Montreal (administrative region); On-site; CAD 110,000 - 170,000; Full time

Job summary

Replimune is seeking a Sr. Scientist Analytical Development to lead method development, qualification, and validation for drug substance and product from preclinical to late-stage clinical development.

The role requires coordination with CMOs/CROs, regulatory filings support, and hands-on data analysis to ensure robust analytical capabilities within a cGMP setting. Based in Milton Park, on-site 5 days a week.

Qualifications

• B.A. or B.S. in a relevant biological science; MS/PhD preferred.
• 5–10 years of industry experience in a cGMP quality environment.
• Experience with GMP testing and regulatory trends in analytics and product development.

Responsibilities

• Develop, qualify and validate analytical test methods and transfers per ICH and regulatory guidances.
• Support release and stability testing in house and at CROs; lead investigations (CAPA, OOS).
• Develop strategies to implement new analytical technologies within Analytical Development.
• Support process development, set specifications, and assist with CMC regulatory filings and responses.
• Participate in routine troubleshooting and data analysis within the AD group.

Skills

Analytical development

GMP experience

Regulatory knowledge

Data analysis

Communication skills

Cross-functional collaboration

Education

B.A./B.S. in biological sciences

M.S./Ph.D. preferred

Job description

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because

patient’s lives depend on it.

At Replimune, We Live By Our Values

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

Summary Of Job Description

Sr. Scientist Analytical Development is responsible for developing, optimizing, qualifying, and validating analytical methods based on new and existing methodologies to qualitatively and quantitatively evaluate both drug substance and drug product, from preclinical through late phase clinical development. Analytical development supports drug substance/drug product release, process development, and characterization and/or stability testing of Replimune’s clinical material. In addition, coordination of analytical development and analysis work at CMOs/CROs will be a significant portion of the duties of the Sr. Scientist Analytical Development.

• This position is based in our Milton Park location and typically has a 5-day on-site expectation.

Key Responsibilities

• Manage the development, qualification and validation of analytical test methods and technology transfer in accordance with ICH and other regulatory guidances.
• Support release and stability testing performed in house and at contract research organization (CRO), and directing good manufacturing practices (GMP) investigations including deviation root cause analyses, corrective action preventative action (CAPA), and out of specification (OOS).
• Develop strategies for evaluating and implementing new technologies within Analytical Development.
• Support process development, setting of specifications, and chemistry manufacturing and control (CMC) regulatory filings and responses.
• Involved in daily workings of the group and actively participate in method troubleshooting and data analysis.

Other Responsibilities

• Supervise the work of Assay Development Scientists or Technicians
• Analytical Development (AD) representative for cross function meetings/projects with manufacturing, Quality Assurance (QA), Regulatory Affairs and external partners.
• Provide AD review and approval of SOPs, risk assessments, protocols and reports.
• Provide regular updates of AD group activities to the Chief Operating Officer and other Replimune senior management.

Educational Requirements

Education will be appropriate to specific job requirements. The following educational requirements are a minimum:

• B.A or B.S. degree in a relevant biological science. M.S., Ph.D. or other post-graduate degree in biochemistry or related science is preferred

Experience And Skill Requirements

Training and experience will be appropriate to specific job requirements. The following categories will be assessed in each case:

• 5-10 years industry experience, preferably in a cGMP Quality environment
• Experience working in a GMP testing environment with an understanding of regulatory requirements and trends related to analytics and product development.
• Thorough understanding of current regulatory requirements and practical experience of QC testing in support of cGMP operations
• Ability to interface effectively with management and other groups or project teams
• Computer processing literacy and experience in statistical analysis
• Excellent verbal and written communication skills
• Good organizational skills

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. We are an Equal Opportunity Employer.