11 manufacturing jobs found in Waltham

Alkermes, Inc. Job Title Senior System Analyst III - Clinical Manufacturing Suite Location Waltham, MA (Hybrid Office Schedule) Position Summary The IT Senior System Analyst III for Clinical Manufacturing Suite will lead all technology implementation, production support, and maintenance activities within the Clinical Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding and validating new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS. Partnering closely with CMC, quality, and regulatory teams, the IT Senior System Analyst III ensures alignment with FDA and global regulatory standards while fostering continuous improvement, operational excellence, and strong collaboration across the organization. The role requires deep...

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! We are seeking an experienced and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play a key role in aligning technology initiatives with business goals, driving efficiency, and enabling innovation across the bioprocessing manufacturing and product development lifecycle.This position requires strong collaboration with business leaders and IT colleagues to evaluate,...

Alkermes, Inc. Position: Director, Process Development Position Summary: An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is responsible for leading and empowering the Process Development Team in taking Alkermes' drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs. Responsibilities and Requirements: Lead process development strategy for...

Repligen Overview Responsible for performing the physical tasks involved in the shipping, receiving, storing, and distributing of products, materials, parts, supplies and equipment. Unpacks and checks goods received against purchase orders or invoices, maintains records of received goods, rejecting unsatisfactory items where necessary. Pulls and fills orders. May use (but not limited to) power equipment such as a forklift, hand tools, and other devices operated in a warehouse environment. This position is not responsible for operating delivery trucks which require a Commercial Drivers License. Prepares and maintains records of merchandise shipped. Posts weights and shipping charges and prepares goods for final shipment. Examines stocks and distributes materials in inventory and on manufacturing lines. May prepare kitting packages for assembly production. This position is a 1st shift role at our Waltham, MA warehouse facility. Responsibilities Loads and unloads product to...

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! A fast-growing and acquisitive global public company is looking for a strong, experienced, and detail-oriented Senior Director of Finance reporting directly to the Vice President of FP&A. This represents an opportunity to work in a key finance leadership role with significant levels of executive visibility. This role must pay great attention to detail, deliver results, and operate cross-functionally in a rapidly changing environment. This role is a critical business...

CSL Associate Director, Corporate & External Affairs, R&D Portfolio Position Purpose: The Associate Director, Corporate and External Affairs, R&D Portfolio will lead corporate and external affairs strategy for CSL's pipeline. The successful candidate will be responsible for driving communications for key pipeline milestones and clinical trials. They will serve as a strategic partner on R&D policy. They will lead issues and crisis management related to pipeline. In addition, they will strengthen the company's reputation within the Waltham biotech ecosystem and US to enhance and protect CSL's reputation and policy position. Reporting Relationships: Reports to: Head of Corporate and External Affairs, R&D Direct reports to position: 1 Main Responsibilities and Accountabilities: Serve as primary business partner and strategic advisor to SVP, Portfolio Development, SVP, GRAS and VP, Portfolio and Operations Excellence to shape...

Repligen Overview Repligen Corporation (NASDAQ:RGEN) is a life sciences company focused on the development, production and commercialization of high-value consumable products used in the process of manufacturing biological drugs. Our bioprocessing products are sold to major life sciences and biopharmaceutical companies worldwide. Responsibilities This is an unpaid internship position for law students seeking externship academic credit. The expected time commitment is approximately 15-20 hours per week. A hybrid work arrangement is preferred; however, fully remote arrangements may be considered. The intern's responsibilities and learning opportunities will include the following: Assist with and participate in the daily activities and special projects of the Legal Department, and benefit from coaching and mentoring by seasoned in-house attorneys Attend and participate in meetings and presentations Draft memoranda regarding areas of legal interest to the intern,...

Alkermes, Inc. Overview: We are currently seeking an Associate Director to join Technical Operations as process expert to support new product introductions, technology transfers, continually monitor, troubleshoot and improve drug product operations conducted across the network on behalf of Alkermes. This role ensures robust, compliant, and efficient processes for drug product formulation (oral, vial, syringe filling etc). The position requires cross-functional collaboration with functions such as Quality, Regulatory, Supply Chain, R&D and external partners (CMOs). Responsibilities: Build and maintain influential relationships with appropriate stakeholders both internally and externally while providing technical leadership and process engineering expertise to external supply teams to support the management of CMO's in the Alkermes supply network. Lead technical input and guidance on drug product CMO vendor selections activities and product technical transfers in...

Alkermes, Inc. The Manager position within Clinical Supply Chain leads end-to-end supply chain management on single to multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel leading supply activities for complex programs that may require multinational interactions. In addition, they coordinate and lead supply activities with both internal and external partners. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs. Responsibilities Review clinical trial protocols and understand impact on supply Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing the supply requirements plans Create, review, and update...

Repligen Overview Make a global impact-join Repligen. We're united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success-where every voice matters and every contribution drives progress. Join us! We are seeking a highly motivated Technical Applications Scientist to join the OPUS Prepacked Columns Product Management team. In this role you will serve as a technical expert bridging customer experience and product performance by managing post-sales technical inquiries, assessing product complaints and collaborating cross functionally to maintain the high quality and reliability of the OPUS pre-packed chromatography portfolio. This role requires a strong foundation in...

Alkermes, Inc. Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes. We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. This individual will be responsible for providing strategic regulatory direction and managing CMC related activities in close partnership with cross-functional development teams, ensuring compliance with global regulatory standards and alignment with internal program goals. This position is eligible for a hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office. This role is not eligible for fully remote work. Key Responsibilities: Lead...