We discovered, developed and produced the first medicines to target the underlying cause of cystic fibrosis (CF) — the result of more than 20 years of research and development. And we haven’t stopped. We continue to investigate additional potential therapies for all people with CF.

Quality Control Manager – Cell Therapies

The Manager, Quality Control provides oversight of a variety of analytical functions that occur in the QC department supporting testing and reporting of in-process, release, and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities. Wed – Sat (10-hour 4 day work week) first shift

Key Duties & Responsibilities

Coordinates and facilities laboratory activities to meet commitments on-time
Ensures assay readiness with adequate inventory of qualified reagents and trained analysts.
Maintains QC lab in audit ready state with an eye on continuous improvement.
Leads planning, coordination and/or review of method validations, method transfers and/or equipment qualification/requalification
Assist in troubleshooting of analytical methods and/or equipment as required
Authors, review, and/or approves data, SOPs, COAs, analytical methods, protocols and reports
Monitor, track and publish lab metrics
May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent re-occurrence

Required Knowledge/Skills

Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
Strong knowledge of analytical methodologies such as flow cytometry, cell based assays, qPCR, ELISA, BACT, endotoxin and applying/interpretation of GMP requirements
Effective communication skills, both verbal and written
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

Education and Experience:

Bachelor’s Degree in science or related discipline with 8+ years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience
Previous managerial experience (people leader) in a QC or equivalent laboratory setting

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Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

State Government Affairs Director- field-based OR, UT, ID, WY, NM, OK

Director State Government Affairs will be responsible for developing and implementing the company’s state/regional government affairs and public policy strategy. This position will work closely with several functional areas, including patient advocacy, communications, policy, patient advocacy, medical affairs, and commercial, to lead the company’s public policy efforts and advance our company’s goals. Field-based position. Incumbent resides in the region (OR, ID, WY, UT, NM, OK )

Key Responsibilities:

• Developing, coordinating, and leading the company’s state/regional public policy efforts;

• Working collaboratively with communications, patient advocacy, policy, medical affairs, and marketing departments to ensure that state public policy goals are aligned to meet company objectives and most effectively serve the needs of patients;

• Analyzing and monitoring legislation, regulations, and political activity relating to issues that may impact Vertex;

Drives strategy and creates plans of actions to impact policy change;

• Developing and maintaining high-level relationships with government officials, community leaders, advocacy groups, external organizations, and stakeholders to achieve Vertex goals;

• Collaborating with and facilitating advocacy coalitions for specific public policy goals, including rare disease awareness and Vertex’s commercial and pipeline disease area policy issues;

• Leads complex cross-functional initiatives that have impact across the team

• Developing as necessary written analyses, testimony and background materials in support of Vertex objectives;

• Leveraging pre-existing relationships as well as facilitating partnerships with additional community-based organizations and coalitions to reach public policy and company goals;

• In partnership with cross-functional partners, integrating Vertex’s public relations objectives with the state/regional public policy strategy and identifying additional opportunities to increase rare disease awareness and disease burden awareness, especially around Vertex’s commercial and pipeline disease areas;

• Managing contract lobbyists and overseeing compliance with state laws for lobbyist registration, reporting and political contributions;

• Identifying and pursuing additional opportunities to advance our company’s business objectives;

• Fulfilling other duties/projects as assigned;

• Exemplifying Vertex’s core values in fulfilling these job duties.

• Field Travel required 40-50% (Incumbent resides in the region (OR, ID, WY, UT, NM, OK )

Minimum Qualifications

• Minimum of seven to ten years current and relevant experience in state government affairs, state government or at a major trade association with significant direct lobbying experience;

• Demonstrated ability to build and sustain relationships with members of the legislature, administration and other government and community leaders;

• Significant knowledge of state legislative and regulatory systems;

• Demonstrated outstanding strategic planning, communication and presentation skills;

• Bachelor’s degree required (advanced degree preferred) in science, law, government or public policy;

• Pharmaceutical or healthcare sector experience strongly preferred;

• A high level of energy and passion toward patients, science and public health;

• Proven teamwork and collaboration skills, with a demonstrated ability to interact and influence all levels of business;

• Detail-oriented, self-initiating, well-organized and capable of managing multiple projects simultaneously and independently;

• Demonstrated ability to think outside the box and develop innovative solutions;

• Strong understanding of the legal and regulatory environment along with demonstrated integrity on the job;

• A desire to work in the corporate culture of a highly innovative company aimed at redefining health and transforming lives with new medicines.

Grants Manager

The Grants Manager is responsible for the overall management of the grants and sponsorships program in Global Medical Affairs. This role will have responsibility for queries around the submission and review process, including cross-functional training to key internal stakeholders, as well as providing support for the Vertex Award Programs. This role will ensure processes and procedures are conducted according to standards and SOPs established by Compliance, Legal, and Medical Affairs.

Key Duties and Responsibilities:

Provides oversight and full lifecycle management of incoming grant, humanitarian donations, sponsorship and membership requests for Vertex disease areas of interest. This includes oversight of grant committee meetings, contracting, milestone tracking/payments, reconciliations, budget planning and audit readiness
Attends and participates in the Grant Committees
Provides input into the ongoing enhancement of grant and sponsorship processes to ensure compliance with Vertex’s policies, utilizing industry insights and benchmarking data
Creates reports for grants tracking including status reports, metrics and dashboards
Works with the Finance department to develop and track budgets and work with legal on contracting; participate in annual budget and forecasts
Maintains data management systems that effectively support the review/approval process, archiving and maintenance of all grants programs
May provide training on data management systems to new team members
Provides support for one or more of the Vertex Award Programs (Cystic Fibrosis Research Innovation Award [CF RIA], Cystic Fibrosis Vertex Innovation Awards [CF VIA], and Cystic Fibrosis Circle of Care)
Communicates and exchanges complex information with internal contacts (e.g., Global Medical Affairs, Legal, Compliance, Patient Advocacy, etc.) and external applicants

Knowledge and Skills:

Strong communication skills (verbal and written)
Developed project management skills
Strong initiative and problem solving skills
Familiarity with Microsoft Office programs (Word, PowerPoint, Excel, Teams) as well as online meeting platforms (Zoom and GoToMeeting)
Knowledge of relevant guidelines including, but not limited to, medical and regulatory affairs, drug development, FDA and regulatory guidelines (e.g., PhRMA guidelines, OIG, AMA, ACCME, EACCME, Sunshine Act, etc.) and compliance around Grant Programs
Proficiency with Request Management systems
Certified Healthcare CPD Professional (CHCP) preferred

Education and Experience:

Bachelor’s degree in relevant discipline
Typically requires 4 years of experience or the equivalent combination of education and experience

Pay Range:

$121,900 – $182,800