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Supervisor, Quality Assurance Operations
🏢 Moderna
Salary not disclosed
Supervisor, Quality Assurance Operations

ModernaTX, Inc. seeks a Supervisor, Quality Assurance Operations for its Norwood, Massachusetts location.

Heres What Youll Do:

  • On behalf of a global biotechnology company, maintain responsibility for quality oversight of clinical operations.
  • Responsible for ensuring quality oversight of mRNA platform in clinical manufacturing.
  • Provide real-time quality leadership and on-the-floor operational support for the clinical manufacturing team.
  • Make quality decisions that may impact operations, ensuring appropriate escalation.
  • Coordinate training, professional development, and growth of the Clinical Quality Assurance team.
  • Monitor process operations to ensure compliance with procedures and specifications.
  • Demonstrate knowledge of standard manufacturing compliance, quality disposition, and quality system review.
  • Identify risks and communicate gaps for quality and GMP process/systems.
  • Enforce adherence to current Good Manufacturing Practices (cGMPs), standard operating procedures (SOPs), and manufacturing documentation.
  • Partner with manufacturing and support management teams to focus on site initiatives.
  • Oversee and perform review of executed electronic and paper batch record documentation.
  • Support product disposition.
  • Supervise approximately 4 Quality Assurance Operations Associates/Specialists.

Heres What Youll Bring to the Table:

Minimum requirements:

  • Requires a minimum of a Bachelors degree, or foreign equivalent, in Chemistry, Chemical Laboratory Technology, Manufacturing Engineering or a related field and 4 years of experience in the position offered, or as a Quality Assurance Specialist, Sr. Specialist, or related position.
  • Alternatively, employer will accept an Associates degree in the stated fields and 5 years of experience in the stated positions.
  • 4 years of experience must include:
    • Quality assurance in early and late-stage clinical products applying Good Manufacturing Practices (cGMP) and FDA guidelines;
    • Leveraging knowledge of Quality Management Systems (QMS) to review and approve deviations, change controls, and corrective and preventive actions (CAPAs);
    • Collecting, analyzing, and interpreting data related to quality metrics, defect rates, and process performance indicators; and
    • Performing risk assessments and implementing mitigation strategies.
  • May telecommute up to 2 days per week.

Apply at https:///en-US/M_tx (Job ID: R17937) or email resume and cover letter to with subject line: R17937.

At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between.

  • Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
  • Lifestyle Spending Accounts to personalize your well-being journey
  • Family planning and adoption benefits
  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investment opportunities
  • Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

Were focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. 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 contact the Accommodations team at .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

Not Specified
Assembler II
Salary not disclosed
Walpole, MA 2 days ago
Mission-Driven. Honor-Bound. Fairbanks Morse Defense. What's your calling? For the men and women of Fairbanks Morse Defense it's the rapid and effective support of the fleets that entrust us to design, develop, and deliver the best naval power technology on the planet. We're one of the nation's leading marine defense contractors because of the highly trained and dedicated teams that provide reliable power systems, parts, and aftermarket services to the U.S. Navy, Coast Guard, Military Sealift Command, and Canadian Coast Guard. When you join Fairbanks Morse Defense, you join a legacy of commitment that spans 150 years. Fairbanks Morse Defense offers competitive benefits with a wide range of training and development opportunities. Our world-class teams are dedicated to helping every individual achieve their full potential. Discover what it's like to be a part of the Fairbanks Morse Defense team here: II
Job Description
The Assembler is responsible for performing overhaul, assembly, and disassembly for Naval Propulsion Equipment. Blade installation and required.
Key accountabilities:
Perform all work accurately according to required standard processes and meet all quality standards.
Produces the quantity of work as expected and ensures full utilization of all equipment.
Responsible for the upkeep of assigned area, PPE, and tooling.
Use advanced troubleshooting logic to identify complex operation and/or process issues in assigned area.
Follow health, safety and environmental procedures and regulations.
Interpret both drawings and technical instructions.
Follows all established protocols such as housekeeping, tool control, and training plans.
Work as part of an integrated manufacturing team to help the business meet its target.
Uses problem solving skills and identifies business improvements opportunities
Basic Qualifications
High School Diploma or equivalent.
Mechanical aptitude, previous experience
2 years prior experience working in mechanical field
Ability to read, write, comprehend and speak English
Basic knowledge of Microsoft Word, Excel and Outlook.
Must be a U.S. Citizen
Preferred Qualifications:
Proficient with precision measuring tools (Micrometers, Indicators, etc.)
Certified forklift operator.
Skilled in using various cranes and lifting devices.
Fairbanks Morse Defense offers a competitive benefits package including but not limited to, medical, dental, vision, life, and disability insurances, and 401k retirement plan with employer match. In addition, we offer paid time off, paid holidays, paid parental leave, and tuition reimbursement.
Equal Opportunity Employer/Veterans/Disabled
Not Specified
Aircraft Engine Mechanic 3rd Shift
Salary not disclosed
Lynn, MA 2 days ago
Job Description

About GE Aerospace

If you want to do work that really matters among a team of spirited and collaborative individuals, you need to know more about GE Aerospace. We've become a world leader in the design, development and manufacture of advanced aviation technologies including jet engines, components, and integrated systems for commercial and military aircraft. We're a people-first organization that will bring out your best ideas and performance as part of our on-going LEAN transformation. We believe that the world works better when it flies. Do you? If so, come aboard.

Working at our Lynn Facility

Come and elevate your career in a facility that combines a rich tradition of aviation technology with a deep commitment to the future of flight. The GE Aerospace manufacturing site in Lynn designs, produces, assembles, and tests military and commercial aircraft engines and components. With more 2,500 employees and 1.6 million sqft of manufacturing space, we're making a huge contribution to the future of flight. And, considering that very first jet engines were born here in 1942, we clearly are the career home of people who are deeply knowledgeable about building quality engines. What's more, GE Aerospace has invested more than $100 million in our facility in the last five years alone.

By engaging with highly collaborative teams, we're reaching for new Sustainable Aviation Fuel milestones every year. And by encouraging our teams to join us in extensive community service and volunteerism, we're making a difference in all the ways that matter.

Here are just a few of the best reasons you will want to consider us:

  • Do work with a real purpose helping to solve the global challenge of how the world flies more sustainably.
  • Be a part of a global workforce of diverse backgrounds, perspectives, ideas, and experiences where everyone feels supported and respected.
  • Earn merit-based rewards and incentives.
  • Free Onsite Parking.
  • Set work schedule with no mandatory overtime.
  • Work in a climate-controlled building out of the elements.
  • Have opportunities for continuous learning and development.

Job Overview:

This is a challenging opportunity that involves complete assembly, disassembly, test set up, adjustment, and inspection of aircraft engines and major components in accordance with assembly, test or engineering instructions, specifications, and drawings. You'll do set-up and operate a variety of standard and specialized tools and a variety of balance machines to perform all types of balancing operations.

The Ideal Candidate:

We are looking for a team player who is looking to help continue our vision of seeing not only our engines take flight, but their careers as well. Utilizing your training or military experience in the field to provide detail-oriented support on aircraft engine assembly and test functions.

Requirements include:

  • High School diploma or equivalent.
  • FAA Power Plant License; OR 2 years minimum experience aircraft power plant maintenance experience with another company; OR 2 years minimum experience as an aircraft aviation mechanic or equivalent in a branch of the military.
  • Relocation assistance available!

Preferred qualifications:

  • Strong interpersonal and communication skills.
  • Proficient in the use of basic hand and power tools.
  • Experience in the use of precision measuring instruments.
  • Experience with computers, applications, and keyboarding.

Additional Information:

  • If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation for purposes of participating in the application/hiring process with GE. If you are unable or limited in your ability to apply or interview as a result of your disability, you can request reasonable accommodations by emailing us at .
  • Any offer of employment is conditioned upon the successful completion of a background check and drug screen (as applicable).
  • You must have the ability to lift, move, and manipulate fixtures and component hardware up to 45 lbs. with or without reasonable accommodations.

Whether we are manufacturing components for our engines, driving innovation in fuel and noise reduction, or unlocking new opportunities to grow and deliver more productivity, our GE Aerospace teams are dedicated and making a global impact. Join us and help move the aerospace industry forward.

The pay for this position is $32/hr. This position is also eligible for an annual discretionary bonus based on a percentage of your base salary/ commission based on the plan. This posting is expected to close on 12/31/2026.

GE Aerospace offers comprehensive benefits and programs to support your health and, along with programs like HealthAhead, your physical, emotional, financial and social wellbeing. Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach from GE Aerospace; and the Employee Assistance Program, which provides 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Aerospace Retirement Savings Plan, a 401(k) savings plan with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness.

GE Aerospace (General Electric Company or the Company) and its affiliates each sponsor certain employee benefit plans or programs (i.e., is a \"Sponsor\"). Each Sponsor reserves the right to terminate, amend, suspend, replace or modify its benefit plans and programs at any time and for any reason, in its sole discretion. No individual has a vested right to any benefit under a Sponsor's welfare benefit plan or program. This document does not create a contract of employment with any individual.

This role requires access to U.S. export-controlled information. Therefore, employment will be contingent upon the ability to prove that you meet the status of a U.S. Person as one of the following: U.S. lawful permanent resident, U.S. Citizen, have been granted asylee or refugee status (i.e., a protected individual under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3)).

GE Aerospace offers a great work environment, professional development, challenging careers, and competitive compensation. GE Aerospace is an Equal Opportunities Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE Aerospace will only employ those who are legally authorized to work in the United States for this opening. Relocation assistance provided: Yes.

Not Specified
Representative - Outside Sales
✦ New
Salary not disclosed
Milford, MA 1 day ago
Sales Representative - Outside Sales

As a Sales Representative - Outside Sales, you will be responsible for developing new prospects and interacting with assigned customers to increase sales and margin of the company's products and/or services. Your primary focus will be face-to-face selling and account management activities to meet sales revenue. You will be expected to engage with all levels of the customers' organizations including technical, operations, supply chain and executive management. You may be required to develop and deliver sales bids, presentations, proposals and/or product demonstrations.

Responsibilities:

  • Assess customer needs and suggest products, services and/or solutions and ensure a smooth sales process.
  • Executes and expands assigned customer account plan(s) which is developed in conjunction with management.
  • Executes on billing margin initiatives through value added services, marketing programs, and supplier engagement.
  • Prospects potential customers, including cold calling and developing leads through referral channels.
  • Communicates with customers and leads to identify and understand their product or service needs; identifies and suggests products and services to meet those needs.
  • Demonstrates the functions and utility of products or services to customers based on their needs.
  • Ensures customer satisfaction through ongoing communication and relationship management; resolves any issues that may arise post-sale.
  • Maintains communication with existing and previous customers, alerting them of new products, services, and enhancements that may be of interest.
  • Utilizes sales management tools for sales planning, supplier planning and documenting opportunities.
  • Develops and grows product knowledge through Wesco and supplier training.
  • Develops strong relationships with suppliers, including performing regular joint sales calls.
  • Provides quotations directly or in conjunction with sales support team.

Qualifications:

  • Valid Driver's License, with a satisfactory driving record required
  • High School Degree or Equivalent required; Bachelor's Degree is preferred
  • Prior sales experience required, outside sales preferred
  • Two years of industry experience preferred
  • Ability to travel to current and potential clients and suppliers
  • Ability to work flexible schedule and occasional overnight travel
  • Excellent sales and negotiation skills
  • Ability to develop and deliver presentations
  • Strong interpersonal skills
  • Effective communicator both written and verbally
  • Ability to work in team environment
  • Strong Microsoft Office Suite skills
  • Knowledge of advertising and sales promotion techniques (Preferred)
  • Ability to travel locally 50% - 75% of the time

Working Environment: Outside Sales Work is generally performed in an office environment, but employee may need to travel to customer sites or warehouse facilities. Driving may be required for an extended period of time with frequent stops and starts. Can be exposed to outdoor weather conditions.

Compensation Details: $65,173 - $104,277 Annually

This amount is what we reasonably believe we will pay for the position; however, offer amounts may vary based on factors such as geographic location, relevant education, experience, qualifications, skills, shift, or any collective bargaining agreements. For eligible positions, compensation may include participation in a bonus or sales incentive plan, subject to the terms and conditions of the applicable plan documents. For certain sales roles, Wesco also offers a commission structure that provides additional compensation based on sales results, as defined by the applicable commission plan.

In addition, Wesco offers a benefits program for eligible employees, which may include paid time off, medical, dental, and vision coverage, and retirement savings plans. Additional details about benefits are available here.

Not Specified
Commercial Real Estate Agent
✦ New
Salary not disclosed
Boston, MA 1 day ago
Sales Professional Opportunity

The Boston office of Marcus & Millichap is expanding, and we are seeking a driven, entrepreneurial, and capable sales professional to join our real estate investment sales team.

Our ideal candidate possesses the following attributes:

  • Self-motivated, ambitious, and inspired to succeed
  • Above-average communication and relationship-building skills
  • A high level of personal responsibility, honesty, and empathy
  • Goal oriented, with a focus on personal development
  • Able to bounce back from rejection, and solve problems creatively

As a leader in the investment brokerage industry, Marcus & Millichap maintains a proven agent development model that offers significant earnings potential and no glass ceiling on your income no real estate experience or license is required to apply.

As an independent contractor, this role is 100% commission based, and not eligible for company paid benefits.

A day in the life of our agents often includes:

  • Advising clients in the development and execution of their individualized real estate investment strategies
  • Preparing thoughtful analyses of clients' properties, including broker opinions of value (BOV), market comparables, and research
  • Researching the local market and staying up-to-date on industry trends
  • Marketing exclusive property listings to qualified buyers
  • Prospecting new client relationships, and networking with other industry professionals
  • Negotiating exclusive listing agreements, and purchase and sales agreements
  • Participating in best-in-class training and ongoing skills-development workshops

What makes Marcus & Millichap different?

  • National Platform MNet, our internal, proprietary listing program, offers our agents the ability to view all active listings within the firm, and bring qualified buyers to any listing. This culture of collaboration & information sharing is a founding principle of the firm.
  • Training & Mentorship Programs Marcus & Millichap provides structured, industry-leading training programs tailored to your individual level of business, sales, and real estate experience. Our team-oriented environment enables newer agents to learn from influential, highly successful senior agents and managers.
  • Non-Competitive Management Our management team is there to train, coach, and support our Agents in growing their businesses; they are no longer brokering deals themselves. Our management team ensures we have the best-prepared, most knowledgeable Agents in the market.

Our mission is to help our clients create and preserve wealth by providing the best real estate investment sales, financing, research, and advisory services available.

Founded in 1971, Marcus & Millichap (NYSE: MMI) is a leading commercial real estate brokerage firm focusing exclusively on investment sales, financing, research, and advisory services, with nearly 1,700 investment sales and financing professionals in 80+ offices throughout the United States and Canada.

Marcus & Millichap closes more transactions than any other real estate investment brokerage firm in the nation. In 2024, the firm closed 7,836 transactions with a sales volume of approximately $49 billion.

The firm has perfected a powerful property marketing system that integrates broker specialization by property type and market area; the industry's most comprehensive investment research; a long-standing culture of information sharing; relationships with the largest pool of qualified investors; and state-of-the-art technology that matches buyers and sellers.

Not Specified
Distribution Center Associate
✦ New
🏢 Amazon
Salary not disclosed
Fall river, MA 1 day ago

About the Role

As a Distribution Center Associate, you'll be a crucial part of our logistics operations, ensuring that products are efficiently and accurately distributed to our customers. You'll work in a dynamic environment, handling various tasks from receiving and storing inventory to picking, packing, and shipping orders.

Key Responsibilities

Receiving and Unloading: Inspect, verify, and unload incoming shipments, ensuring they meet quality standards and are properly documented.

Inventory Management: Store and organize products in designated locations, using inventory management systems to track stock levels.

Order Picking: Accurately select products from inventory based on customer orders, using advanced picking technologies.

Packaging and Shipping: Prepare orders for shipment by packing them securely and applying appropriate shipping labels.

Quality Control: Inspect products for defects or damage before shipping to ensure customer satisfaction.

Safety and Compliance: Adhere to safety regulations and procedures, including wearing appropriate safety equipment.

Qualifications

High school diploma or equivalent

Ability to lift and move heavy objects

Strong attention to detail and accuracy

Ability to work in a fast-paced, physically demanding environment

Experience in a warehouse or distribution center is preferred but not required

Benefits

Competitive wages

Comprehensive benefits package, including medical, dental, and vision insurance

Retirement savings plans

Employee discounts on company products

Opportunities for career growth and development

Join our team and contribute to our efficient and reliable distribution operations!

Not Specified
Intellectual Property Transactions Associate
✦ New
Salary not disclosed
Boston, MA 1 day ago

Intellectual Property Transactions Associate

Our client is a major international Am law 100 firm, seeking an associate for its Intellectual Property Transactions Group in New York, Boston, San Francisco, and Palo Alto. Candidates who are interested in working with clients at the intersection of IP, innovation and business strategy are best suited for this role. The salary range for this position is between $260k to $365k.


Qualifications

  • 3-5 years of experience in IP transactions, technology licensing, or related practice areas.
  • Large law firm experience is preferred.
  • Experience drafting and negotiating complex license agreements and other agreements [purchase, software and cloud services agreements, and trademarks involving technology, software, data, and brand assets].
  • Familiarity with AI technologies.
  • Excellent communication skills, with ability to convey omplex legal concepts for clients in the consumer and technology sectors.
  • Excellent interpersonal and client service skills.
  • State bar admission in jurisdiction of practice.
  • All candidates must be authorized to work in the U.S.


About Us

Marina Sirras & Associates LLC is a boutique legal recruiting firm committed to connecting exceptional legal talent with top-tier law firms and in-house legal departments nationwide. With decades of experience and a personalized, relationship-driven approach, we take pride in understanding the unique needs of both our clients and candidates.

We are a proud member of the National Association of Legal Search Consultants (NALSC) and strictly adhere to the NALSC Code of Ethics. Marina Sirras, our founder, is a former President and Chairperson of the organization, reflecting our longstanding commitment to integrity and professionalism in legal recruiting.

To learn more about our team and services, please visit us at

Not Specified
Director, CMC Regulatory Affairs
✦ New
Salary not disclosed
Boston, MA 1 day ago

About the Company

We are seeking an experienced Director, Regulatory CMC to provide strategic and operational leadership for Chemistry, Manufacturing, and Controls regulatory activities across a growing portfolio of development and commercial products. This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management. The Director will work closely with Technical Operations, Quality, Manufacturing, and Development teams and will represent CMC Regulatory in interactions with health authorities.


About the Role

This role will serve as the CMC regulatory subject matter expert, ensuring compliance with global regulatory requirements while supporting efficient development, manufacturing, and lifecycle management.


Responsibilities

  • Lead the global CMC regulatory strategy for development and marketed products, ensuring alignment with business objectives and regulatory expectations.
  • Provide oversight and authorship for CMC sections of regulatory submissions, including INDs/CTAs, BLAs/NDAs, supplements, variations, and annual reports.
  • Act as the primary CMC regulatory representative in health authority interactions, including FDA meetings, scientific advice, and regulatory correspondence.
  • Support CMC lifecycle management, including comparability assessments, post-approval changes, and regulatory impact evaluations.
  • Partner cross-functionally with Technical Operations, Manufacturing, Quality, Analytical Development, and Supply Chain to ensure regulatory compliance and readiness.
  • Ensure compliance with ICH guidelines, FDA, EMA, and other global regulatory requirements applicable to CMC activities.
  • Contribute to internal governance forums, risk assessments, and regulatory decision-making processes.
  • Build and maintain effective relationships with external partners, including CDMOs and regulatory consultants.
  • Mentor and develop regulatory staff as appropriate, supporting a culture of regulatory excellence and accountability.


Qualifications

  • 10+ years of Regulatory Affairs experience, with significant focus on CMC in pharmaceutical or biotechnology environments.
  • Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, PharmD) preferred.
  • Demonstrated experience supporting IND, BLA, or NDA submissions, including CMC sections.
  • Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).
  • Experience collaborating with manufacturing, quality, and technical operations organizations.
  • Proven ability to operate effectively in an SME environment, balancing strategic oversight with hands-on execution.
  • Excellent written and verbal communication skills, with the ability to clearly convey regulatory requirements and risk.


Required Skills

Strong working knowledge of global CMC regulatory frameworks (FDA, EMA, ICH).


Preferred Skills

Experience collaborating with manufacturing, quality, and technical operations organizations.


Pay range and compensation package

Competitive compensation and comprehensive benefits.


Equal Opportunity Statement

We are committed to diversity and inclusivity.

Not Specified
Central Processing Supervisor, Core Laboratory
Salary not disclosed
Boston, MA 3 days ago

Central Processing Supervisor, Core Laboratory - Evening Shift

Location: Boston Teaching Hospital


  • Evening Shift: 3p – 11:30p ($3/hr evening diff).
  • Must be ASCP certified (or equivalent).
  • Sign-on bonus eligible.


Responsibilities:

  • Responsible for coordinating the daily operation of the front office of the core laboratory.
  • Oversees all Pre and Post analytic activity on the evening shift, in close conjunction with the day shift MT Operations Coordinator, reference lab staff, and other individuals who oversee areas that have an overlapping operating relationship with Central Processing.
  • Ensures that all activities, processes and policies are carried out in strict compliance with governmental regulations, licensing agency standards, and hospital policies and procedures.
  • Responsible for day-to-day general management including staffing, schedules, payroll, performance management, training, education, development of policy and protocol, compliance, and safety.
  • FTE's: 25+/-.
  • Reports to the Technical Director of Pre/Post Analytics in the Core Laboratory.


Qualifications:

  • MT (ASCP) or equivalent.
  • Bachelor’s Degree in Medical Technology or physical sciences.
  • 4+ years of hospital laboratory experience, including knowledge of &/or experience with pre/post analytics &/or central processing.
  • 1+ years of leadership experience.
  • Preferred: experience overseeing non-exempt hourly staff.
Not Specified
Senior Process Engineer - Chemical
✦ New
Salary not disclosed
Lee, MA 1 day ago

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.


This role will:

  • Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
  • Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
  • Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
  • Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
  • Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
  • Identify and order materials required to perform development and manufacturing
  • Identify tooling and equipment required to perform development and manufacturing
  • Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
  • Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
  • Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
  • Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
  • Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
  • Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
  • Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
  • Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
  • Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
  • Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
  • Lead/support validation activities including equipment validation and process validation
  • Lead problem solving and investigate quality events related to formulation process or batch records
  • Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
  • Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
  • Supervise, mentor and develop team members or relevant personnel across departments


This role requires:

  • A minimum of three (3) years of experience in pharmaceutical research and manufacturing
  • Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
  • Experience in sterile manufacturing is preferred
  • Experience in lyophilization and terminal sterilization techniques are a plus
  • Knowledge of parenteral drug product manufacturing
  • Proficient with calculation, data analysis, statistics and applied mathematics
Not Specified
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