Associate Director, Operations, Bioanalytical and Biomarker Development

Company: Alexion Pharmaceuticals,Inc
Location: New Haven
Posted on: September 12, 2020

Job Description:

Career Opportunities: Associate Director, Operations, Bioanalytical and Biomarker Development (22187) Req Id  22187  - Posted  09/04/2020  -  United States  -  New Haven, CT  -  Research

The Associate Director of Bioanalytical and Biomarker will serve as a centralized role to manage regulated bioanalytical lab activities, compliance activities, and strategically utilize internal and external resources, systems, and tools to improve Bioanalytical Development’s compliance, quality, and operational efficiency. This individual will serve as the primary point of contact and coordination on regulatory compliance issues for and with our internal and partner line stakeholders and will also play a leadership role in the definition, communication, and implementation of Bioanalytical Development’s compliance strategies and practices.

Job Duties & Responsibilities

The primary point of contact for compliance activities for Bioanalytical and Biomarker Development and vendors utilized for regulated activities

Develop compliance goals, priorities and strategic planning

Assist the head of the Bioanalytical Development to support regulated studies

Implement quality systems throughout Bioanalytical and Biomarker Development in alignment with corporate goals

Provide compliance expertise to staff and management through detailed knowledge of regulatory requirements

Partner with R&D Quality, other R&D functions, and external organizations (e.g., SQA and PhRMA to obtain a detailed interpretation of regulatory requirements

The primary point of contact to manage internal and external QA and regulatory inspections and coordinate responses

Monitor general internal and external audit finding trends and incorporate reasonable actions within compliance systems and process to address risk areas

Coordinate inspection readiness activities

Essential Qualifications

Work experience in pharmaceutical, biotechnology for at least ten years

Very strong organizational skills and an excellent understanding of the contracts and budget process

Strong knowledge in GXP regulations and other relevant international regulations and bioanalytical regulatory requirements and guidelines

Strong experience in the regulated bioanalytical environment

Strong interpersonal skills

Excellent organizational skills and ability to prioritize tasks based on project timelines, and capable of handling multiple tasks/projects simultaneously

Excellent verbal, written communication, and technical writing skills.

Preferred Qualifications

BS/MS. in biology, or bioanalytical chemistry in a relevant biological science field with a minimum of 8 years of experience in compliance/quality area.

*LIDI-1

Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com .

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.

Keywords: Alexion Pharmaceuticals,Inc, New Haven , Associate Director, Operations, Bioanalytical and Biomarker Development, Other , New Haven, Connecticut