Associate Director, Manufacturing Science and Technology Job at Apogee Therapeutics

Associate Director Digital Workplace and IT Operations

The Associate Director of Digital Workplace and IT Operations is responsible for...

Location

United States , Alpharetta

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Information Technology, or a related field
10+ years of progressive IT experience, including at least 5 years in a leadership capacity managing global IT operations and digital workplace environments
Proven success leading enterprise-scale ITSM and Service Desk transformations, with oversight of outsourced global Service Desk functions
Minimum 2+ years of experience managing ServiceNow or equivalent ITSM platforms
Demonstrated success in implementing and managing enterprise MDM, SCCM, AVD, and O365 environments
Extensive background in managing and securing IT environments within public cloud platforms (Azure preferred)
Strong record of delivering technology-driven improvements in user satisfaction, cost efficiency, and service performance
Ability to resolve complex technical and business challenges in a fact-based, results-oriented manner while maintaining strong stakeholder relationships
Excellent communication, leadership, and negotiation skills with demonstrated cross-functional collaboration
Proven capability managing multiple on-site, off-site, and vendor-sourced service teams

Job Responsibility

Oversee the ITSM framework and ensure alignment with ITIL best practices
Lead global IT Service Desk operations to provide high-quality, responsive support for all end users
Lead site IT operations to ensure consistent end-user experience across offices and manufacturing locations
Manage and optimize the Microsoft 365 platform
Oversee Azure Virtual Desktop and Cloud PC operations for remote and hybrid workforce enablement
Manage the enterprise MDM platform to ensure secure and compliant use of mobile devices
Oversee configuration management, software distribution, and patch deployment across all endpoints using SCCM
Oversee management of global printing environments
Ensure reliable AV/VC systems for conference rooms and hybrid collaboration environments

What we offer

comprehensive and competitive range of benefits
generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria
HQ region voted 'best place to live' by USA Today
uncapped sales commissions

Fulltime

Associate Director, R&D Product Development, Wellbeing Collective

The Americas & EU Technical Leader, Wellbeing International R&D is responsible f...

Location

United States , Trumbull

Salary:

146200.00 - 219400.00 USD / Year

Unilever

Expiration Date

Until further notice

Requirements

Strong R&D TPL experience (senior-level)
Deep expertise in gummy formulation
Based in China with Mandarin fluency to speak to the manufacturers in China
Experience working on TPL projects beyond China, ideally with a regional or global lens
Bachelor's degree required in science or engineering
BS with 12+ years, Masters with 10+ years, or PhD with 7+ years’ experience in formulation development or technology development of which at least 3 years as Technical Project Lead
Excellent understanding of Product development Principles – formulation development for consumer-friendly ingestible dosage forms such as Powders, Gummies/capsules, material understanding, product scale up, product costing, ingredient sources and GMP
Experience working with cross functional teams across geographies
Ability to lead more complex portfolio of innovation/quality & Value Improvement Project (VIP) projects including multiple brands/regions/technologies
Technical leadership by exhibiting and fostering initiative, motivation, judgment, flexibility, and breadth

Job Responsibility

Drive best-in-class product development to support growth ambitions of the Wellbeing Collective international business
Lead innovation and new market entry across Canada, Latin America, the UK, and Europe for WBC brands
Own end-to-end technical delivery for innovation and market expansion
Partner closely with cross-functional teams (Marketing, Supply Chain, Procurement, SERs, Nutrition Science, Quality, and Regulatory) to deliver projects on time and in compliance
Build and deliver a robust innovation pipeline in partnership with the global marketing team
Drive cost savings and strategic business continuity initiatives
Lead and develop a team of formulators and process engineers
Lead end-to-end product development and commercialization
Design cost-effective, sensorially superior, and scalable formulations
Own technical delivery on project teams

What we offer

Health insurance (including prescription drug, dental, and vision coverage)
Retirement savings benefits
Life insurance and disability benefits
Parental leave
Sick leave
Paid vacation and holidays
Access to numerous voluntary benefits
Bonus eligible
Long-Term Incentive (LTI) eligible

Fulltime

Associate Director, Quality Control Technical Services

Beam Therapeutics is a biotechnology company committed to establishing the leadi...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D) in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline, with 8+ years of relevant industry experience in Quality Control, Analytical Development, or CMC within biologics, cell therapy, or gene therapy
Extensive hands-on experience with ex vivo autologous cell therapies, including CD34+ cell-based products, across late-stage development, validation, and/or commercial readiness
Demonstrated technical expertise in cell handling and testing methodologies, including functional and potency assays, flow cytometry, NGS-based assays, and separation sciences. Experience with analytical method automation, qualification, and validation is strongly preferred
Proven understanding of analytical method lifecycle management, including method transfer, qualification, validation, performance monitoring, remediation, and comparability, particularly for late-stage and commercial products
Strong working knowledge of US and EU regulatory expectations (e.g., FDA/CBER, EMA, ICH, USP) applicable to cell and gene therapy CMC, with the ability to apply guidance in a phase-appropriate and inspection-ready manner
Direct experience supporting regulatory submissions (INDs, BLAs, amendments, post-approval changes) for cell and gene therapy products, including specifications, method validation reports, and responses to health authority questions
Demonstrated ability to lead and influence cross-functional program teams, partnering effectively with CMC, Manufacturing, Analytical R&D, Quality Assurance, and Regulatory Affairs in a fast-paced, matrixed environment
Strong communication and leadership skills, with a track record of clearly articulating technical strategies, aligning stakeholders, and driving decisions across functions and with external partners
Documented success in driving complex, program-critical initiatives to completion on time and within budget, including managing dependencies, risks, and priorities across multiple workstreams
Highly developed organizational, analytical, and problem-solving skills, with the ability to interpret complex datasets, assess risk, and translate data into actionable QC and CMC strategies

Job Responsibility

Lead and influence QC CMC strategy in partnership with cross-functional CMC teams for master cell banks (MCBs), plasmids, and mRNA drug substance and critical materials, supporting both ex vivo and in vivo therapy programs across development and commercialization
Define and execute the QC testing, method strategy, and technical execution to enable next-generation autologous cell therapy manufacturing processes, including analytical readiness for process validation, comparability, and technology transfer
Own and coordinate analytical method transfer, qualification, and validation activities across internal and external QC laboratories, ensuring compliant, phase-appropriate, and inspection-ready execution
Establish and maintain analytical control strategies by tracking and trending in-process, release, and stability data, collaborating with statisticians and program teams to define and justify specifications for MCBs, plasmids, mRNA, and autologous cell therapy products
Define and oversee stability strategies and programs for MCBs, plasmids, mRNA, and ex vivo cell therapy products, ensuring alignment with regulatory expectations and lifecycle needs
Lead analytical method lifecycle management for late-stage and commercial ex vivo portfolio, including method performance monitoring, remediation, comparability activities, and continuous improvement
Drive the internalization of validated mRNA analytical methods into Beam's North Carolina Quality Control laboratory, strengthening internal capabilities and supporting long-term commercial supply
Author and review Quality System documentation, including SOPs, Change Controls, and CAPAs, to support method implementation, lifecycle changes, and inspection readiness
Partner with Regulatory Affairs-CMC to author, review, and coordinate CMC sections of regulatory submissions, including specifications, method validation reports, and responses to agency queries
Ensure QC visibility and alignment on regulatory interactions, including tracking agency questions, commitments, post-approval requirements, and method introduction or change strategies

Fulltime

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Andrologist III

The Andrologist III plays a critical role in supporting daily operations within ...

Location

United States , Beachwood

Salary:

36.88 - 57.68 USD / Hour

University Hospitals

Expiration Date

Until further notice

Requirements

Master's Degree Masters of Science in a Biological Science (Preferred)
Bachelor's Degree or minimum of Bachelors in Science (Required)
5+ years with a Bachelors in Science (Required)
3+ years with a Masters in a Biological Science (Required)
Extensive knowledge of reproductive biology including male reproductive system and Assisted Reproductive Technology
Proficient in all Andrology techniques and procedures
Appropriate knowledge of Microsoft office, excel, PowerPoint, and Access
Excellent communication skills
Demonstrates leadership qualities
TS Certification from the American Association of Bioanalytics (Required)

Job Responsibility

Assist Supervisor with oversight of laboratory operations and personnel performing testing
Assist with training new Technologist
assist in identifying continuing medical educational opportunities for lab personnel
Ensures operation of equipment
follows manufacturer’s instructions
calling for repairs
maintain equipment inventory' assist in evaluating new equipment and techniques
Resolves technical problems in accordance with policies and procedures established by Lab director and/or Supervisor
Monitors test performance
ensures that remedial action is taken when test systems deviate from the laboratories established performance specifications

What we offer

healthcare
dental
vision
retirement plan options
additional offerings

Fulltime

Director - Site Validation

At Amgen, our mission is to serve patients. At our Dun Laoghaire (ADL) site, we ...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly relevant experience
Master’s degree and 8 years of directly related experience
Bachelor’s degree in Engineering, Life Sciences, or associated discipline and 10 years of directly related experience
Within experience must have 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources
Extensive experience in validation within a sterile/aseptic manufacturing environment (fill-finish highly preferred)
Strong expertise in: Aseptic process simulation (media fills)
Cleaning validation
Equipment qualification and lifecycle management
Commissioning and qualification (CQV) for capital projects
Proven experience supporting large-scale capital project delivery and facility start-ups

Job Responsibility

Strategic leadership for all site validation activities, ensuring alignment with Amgen global standards, regulatory requirements, and site objectives
Leading and developing a high-performing Validation organisation, setting clear expectations and fostering a culture of quality, compliance, accountability, and continuous improvement
Development of the organisation includes robust succession planning as well as a focus on how the function will support 24/7 operations e.g. via a new validation shift team
Owning all validation lifecycle activities including: Aseptic Process Simulations (media fills) strategy and execution
Airflow Visualisation Studies (AVS) and HVAC requalification programs
Sterilisation validation (VHP, autoclaves, SIP/CIP, lyophilisation)
Cleaning validation programs
Equipment validation
Facilities and Utilities
Effective continued process verification and lifecycle validation, including periodic review, requalification and data-driven performance monitoring programs

What we offer

Vast opportunities to learn and move up and across our global organisation
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan — including health, finance, and wealth benefits
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Project Leader

Undertake the organizing, coordinating and controlling of all stages of project ...

Location

Canada , Pickering

Salary:

75.00 - 82.00 CAD / Hour

Morson Talent

Expiration Date

Until further notice

Requirements

Requires a knowledge of project management principles, specifically the 5 primary project phases (Identification, Initiation, Definition, Execution, Closeout)
Requires a knowledge of economics and business principles to provide project cost estimates and forecasts
This level of knowledge is normally acquired by successful completion of a 4-year university degree in Engineering/Applied Science plus completion of post-secondary courses in project management and business economics as it relates to project and asset management or by having the equivalent level of education
Requires the following experience, knowledge and abilities: Project management, specifically, experience in developing project requirements and plans, preparing cost estimates, participating in request for proposal and contract bidding and award processes, managing projects in execution phase, and managing project closeout
Managing conflicting priorities of scope, schedule, cost and quality
Familiarity with equipment and processes in generating station or similar heavy industry
Solving problems and providing guidance
Knowledge of cost accounting and forecasting as it relates to project management
Knowledge of commercial contracting methods, contract management, construction methods, codes and standards, quality assurance and health and safety
Strong organizational skills

Job Responsibility

Undertake the organizing, coordinating and controlling of all stages of project management in accordance with Project Management governance for assigned projects or project packages in all project phases from initiation to closeout, as circumstances require
Utilize approved Project Management processes for phase-gating, integration, scope, schedule, cost, change control, estimating, communications and reporting, and risk
Perform project management activities throughout the lifecycle of assigned projects, ensuring all project objectives and commitments are controlled and delivered within targets of safety, quality, budget and schedule
Provide input into the preparation of project background information, contribute to scope and constructability reviews, assist in the preparation of Business Case Submissions to senior management, the Executive Office and the Board of Directors, for project approval and the release of funds
Prepare and coordinate the preparation of all information pertinent to an assigned project and alternatives to be considered for input into planning
Review, provide input into, and accept project charters for assigned projects
Initiate and coordinate scopes of work (WBS), estimates, schedules, risk management plans, project management plans, gate packages, and contract performance specifications
Develop structures for estimating and controlling project cost and schedule
Gather input from stakeholder departments and agencies to ensure project requirements are captured and detailed in the estimate and execution plans
Arrange for application to, and negotiate with internal and external agencies for all necessary approvals, licenses, permits or clearances required

Fulltime

Sr Director, MSAT

The Sr. Director, MSAT (Manufacturing Sciences, Analytics, and Technology) acts ...

Location

United States , Bedford

Salary:

Not provided

PCI Pharma Services

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences or equivalent experience required
Minimum of fifteen (15) years of relevant experience in cGMP manufacturing or equivalent
Proven experience leading innovation, managerial experience with extensive industry knowledge and an eye towards future technologies
Soft skills: Strategic thinking, adaptive thinking, and strong critical mindset. Strong business acumen and presentation skills. Excellent interpersonal, leadership, and communication skills. Impact & influence top leaders & external clients and regulators
Emphasis on aseptic processing and compliance required
Advanced-level verbal communication skills

Job Responsibility

Optimize the use of resources (human, fill finish equipment and support areas) across the organization in support of improving process robustness and forward-looking capabilities
Coordinates and supports cross functional teams with recommendations, advice, and action plans for complex investigations, change controls, gap analyses and risk assessments related to all manufacturing modalities
Oversees authoring and revision of compliance, change controls and other technical documentation to support critical MSAT changes
Assesses incoming client projects to ensure compatibility, compliance, and initial and ongoing profitability with AAI processes
Contributes advanced level support to internal and client audits when needed
Build and sustain common innovation roadmap between MSAT and Drug Product Manufacturing/Finishing to ensure continuum in innovation to accelerate client projects and sustainable process performance
Lead the client technical intake process team composed of engineers and specialists
Drive complex change management & anchor the changes in MSAT and with connected functions, Drug Product, Finishing, Quality Assurance and Quality Control
Responsible for exhibiting professional behavior with both internal and external business associates that reflect positively on the company and is consistent with the company’s policies and practices
Serves as key contact for clients during tech transfer and post manufacturing activities

Fulltime

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Associate Director, Manufacturing Science and Technology

Job Description

Job Responsibility

Requirements

What we offer

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