Associate Director, Quality Sterility Assurance and Aseptic Controls - Boston, United States - Vertex Pharmaceuticals

Vertex Pharmaceuticals Boston, United States

3 weeks ago

Description

Associate Director, Quality Sterility Assurance and Aseptic Controls (Boston) page is loaded

Associate Director, Quality Sterility Assurance and Aseptic Controls (Boston)

Apply

locations

Boston, MA

time type

Full time

posted on

Posted 5 Days Ago

job requisition id

REQ-21267

Job Description

GENERAL POSITION SUMMARY

The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing.

This role will partner with stakeholders to define strategies for microbial control activities in key areas that include facility and equipment design and qualification (e.g. cleanroom, isolators, autoclaves, etc.), environmental qualification and monitoring programs, and operational practices (e.g. gowning, cleaning and sanitization, etc.).

This individual will interface with internal and external manufacturing sites to support the maintenance of critical cGMP aseptic activities and provide technical support for the overall contamination strategy and facility monitoring programs.

The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs.

In addition, the successful candidate will be experienced in the fields of aseptic process technologies, microbial testing, environment and critical utilities monitoring programs, and in the design, commissioning, and qualification of facilities, utilities, and equipment systems.

This role will report to the Director of Quality Validation and Engineering within the Vertex Cell and Genetics Therapies QA group.

KEY DUTIES AND RESPONSIBILITIES
Sterility Assurance and Aseptic Controls

Provide quality oversight and technical support across all project phases from design, commissioning, and qualification of cGMP manufacturing facility startups, manufacturing systems, critical utilities, and analytical instruments in support of aseptic manufacturing of cell and gene clinical and commercial products.

Support environmental qualifications for cleanrooms, isolators, and biosafety cabinets. Additionally, support the qualification of autoclave systems, disinfectant efficacy studies.

Support the design and implementation of risk-based approaches and strategies designed to control bioburden and prevent contaminations in cell-based processes for drug substance and drug product manufacturing sites.

Provide quality oversight of the environmental and utilities monitoring programs for Vertex CGT facilities, technical input into

environmental/facility

monitoring program excursions and identified trends, and contamination events to determine impact to batch disposition.

Provide SME support for sterility assurance and aseptic controls related investigations including support the design and implementation of effective corrective and preventative actions to prevent future recurrence.

Responsible for review and approval of EM and UM program trending reports.
Provide analytical testing strategies for environmental viable and non-viable testing and associated methods.

Work closely with business colleagues to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.

Operations – Facilities, Validation, and Engineering Support
Collaborate with internal and external (CDMO) project teams and provide QA support for assigned CAPEX and OPEX projects.

Project scopes may include large projects to design, construction, fit out, qualification and startup of new facilities for the manufacturing, testing, and or storage of cell and gene therapy products.

Responsible to support all project phases from conceptual design, through commissioning and qualification for GMP release.

Support validation maintenance program including the review and approval of periodic assessments and requalification activities.

Provide oversight for various facility control programs that include facilities and equipment maintenance and calibration program, qualified system monitoring and alarm system (EMS), and facility pest control program, including the review and approval of associated trend reports.

Support annual plant shutdown and other planned area shutdown activities, including providing guidance on containment and other controls to minimize impact on cleanroom spaces, provide technical support and strategy for return to service cleaning, testing, and GMP release of the facility.

Serves as QA document approver for processes/programs in the Facilities, Validation and Engineering spaces and responsible for identifying risks, communicating gaps, and driving mitigations and process improvements to address.

Audit / Inspection Support

Serves as quality subject matter expert (SME) for aseptic and facility control programs in scope of responsibilities outlined in this job description along with the associated validation lifecycle elements.

Participate in inspection readiness activities and provide support during regulatory site inspections. Provide post inspection support to address any regulatory observations.
Deployment of QMS and Establishment of Compliance Expectations
Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
Reviewer and/or approver of SOPs and Work Instructions as assigned.

Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner.

Contribute to the design, development and implementation of GMP topic specific training program.

REQUIRED EDUCATION AND EXPERIENCE
Demonstrated aptitude for facilitating group or project team endeavors and building team unity
Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process
Demonstrated ability to work independently to provide QA support for large, multifaceted projects

Experience in an aseptic drug product technical role in process development and/or manufacturing for biologics and/or cell therapy products and demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.

Deep understanding of technical and operational aspects of late phase to commercial GMP aseptically processed drug substance and drug product manufacturing regulations and excellent written and verbal communication skills.

Prior experience supporting aseptic drug product manufacturing activities across multiple modalities (e.g., sterile dosage form, devices, etc.) and design of sterility assurance and facility monitoring programs is

desired.

Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.

Experience with qualification of manufacturing equipment, laboratory instrument, and facility and utility system in a cGMP setting.
Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Experience with system automation, and network-based applications such as Oracle and Veeva preferred.
Advanced degree (PhD or equivalent) in biological (microbiology preference) and/or engineering disciplines with minimally 10 years of relevant experience in biotech or pharmaceutical industries, ideally in a technical leadership role in a cGMP facility
#LI-AR1
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

Similar Jobs (5)

Associate Director, Quality Product Complaints / Recalls

locations

Boston, MA

time type

Full time

posted on

Posted 19 Days Ago

Associate Director, Regulatory Affairs Training

locations

Boston, MA

time type

Full time

posted on

Posted 13 Days Ago

Director, Packaging, Labeling Quality Operations

locations

Boston, MA

time type

Full time

posted on

Posted 30+ Days Ago

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and

transfusion-dependent

beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency

.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London.

Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For.

For company updates and to learn more about Vertex's history of innovation, visit

or follow us on

Facebook

,

Twitter/X

,

LinkedIn

,

YouTube

and

Instagram

.

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths.

By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.

Our vision is clear:

to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

#J-18808-Ljbffr

Associate Director, Quality Sterility Assurance and Aseptic Controls

1 week ago

Vertex Pharmaceuticals, Inc Boston, United States

Job Description · GENERAL POSITION SUMMARY · The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell ...
Pharmacy Intern

3 weeks ago

Partners Healthcare System Boston, United States

Under the supervision of a pharmacist, the Pharmacy Intern assists the pharmacist and performs pharmacy-related functions throughout the department. · * Coordinates daily workload to coincide with the needs of the department. · * Prepacks non-unit-dose oral medications as needed ...
Surgical Technologist

3 weeks ago

Brigham and Women's Hospital Boston, United States

Surgical Technologist · 40 hours rotate · 10k Sign On Bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technologist certif ...
Surgical Technologist

3 weeks ago

Brigham and Women's Hospital Boston, United States

Surgical Technologist I · 40 hour Evening · 10k sign-on bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technologist cert ...
Surgical Technologist

3 weeks ago

Partners Healthcare System Boston, United States

Surgical Technologist I · 40 hour rotating · 10k sign on bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technologist cer ...
Surgical Technologist

3 weeks ago

Partners Healthcare System Boston, United States

Surgical Technologist I · 36 hour rotating · 10k sign on bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technologist cer ...
Surgical Technologist

1 week ago

Partners Healthcare System Boston, United States

Surgical Technologist · 36 hour rotating · 10k sign on bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technologist certi ...
Surgical Technologist

1 week ago

Brigham and Women's Hospital Boston, United States

Surgical Technologist · 36 hour evening · 10k sign on bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technologist certif ...
Surgical Technologist Thoracic

2 weeks ago

Partners Healthcare System Boston, United States

Surgical Technologist Thoracic · 40 hours rotating · 10k Sign On Bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technolo ...
Surgical Technologist

3 weeks ago

Partners Healthcare System Boston, United States

Surgical Technologist I · 36 hour evening · 10k sign on bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technologist cert ...
surgical technologist 40 hour rotating

3 weeks ago

Brigham and Women's Hospital Boston, MA , USA, United States

Surgical Technologist · 40 hour rotating · 10k Sign On Bonus · Position Summary · This is the first level in the surgical technologist career ladder. Incumbents at this level are both entry level and fully competent as surgical technologists and hold a surgical technologist certi ...
Phlebotomy Lab Tech II

1 week ago

Partners Healthcare System Boston, United States

Phlebotomist/Laboratory Technician II greets patients, process paperwork and specimens, and logs all tests into the computer. Performs heelsticks, fingersticks, and venipunctures on all patients to include: Infant (age 0-2) Children (age 2-14) Adolescents (age Adult (age Older Ad ...
QC Analyst II, Microbiology

2 weeks ago

Integra LifeSciences Holdings Corp. Boston, United States

Changing lives. Building Careers. · Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's poss ...
certified surgical technician, operating room

3 weeks ago

Boston Medical Center Boston, MA , USA, United States

Position: Surgical Technician · Department: Menino Operating Room · Schedule: 36 Hours, Perm Evenings, Every Third Weekend, Call Required · POSITION SUMMARY: · As a member of the surgical team, the surgical technician provides patient care during surgical procedures by providing ...
Surgical Technologist

1 week ago

Partners Healthcare System Boston, United States

Surgical Technologist · 36 hours rotating · 10K sign on bonus · Position Summary · This is the second level of the surgical technologist career ladder. Incumbents in this classification are function as fully competent and independent, providing orientation and support to other su ...
Surgical Technologist

1 week ago

Partners Healthcare System Boston, United States

Surgical Technologist · 36 hour nights · Position Summary · This is the second level of the surgical technologist career ladder. Incumbents in this classification are function as fully competent and independent, providing orientation and support to other surgical technologists an ...
Surgical Technologist Ortho

2 weeks ago

Brigham and Women's Hospital Boston, United States

Surgical Technologist · 40 hours · 10k Sign On Bonus · Position Summary · This is the third level of the surgical technologist career ladder. Incumbents at this level function above the standard and may be experts across multiple service lines. They are also involved in in-servic ...
Surgical Technologist Cardio

3 weeks ago

Brigham and Women's Hospital Boston, United States

Surgical Technologist · 40 hours · 10k Sign On Bonus · Position Summary · This is the third level of the surgical technologist career ladder. Incumbents at this level function above the standard and may be experts across multiple service lines. They are also involved in in-servic ...
Surgical Technologist Cardiac

1 week ago

Brigham and Women's Hospital Boston, United States

Surgical Technologist Cardiac · 40 hours rotating · 10k Sign On Bonus · Position Summary · This is the second level of the surgical technologist career ladder. Incumbents in this classification are function as fully competent and independent, providing orientation and support to ...
surgical scrub lpn program

3 weeks ago

Boston Medical Center Boston, MA , USA, United States

Boston Medical Center (BMC) is excited to announce the Surgical Scrub LPN Program in the Operating Room starting July 2024. · The Surgical Scrub LPN Program in the Operating Room provides a hybrid learning opportunity that will involve online modules & videos, classroom didactic, ...