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

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Computer Science, Information Technology, or a related field
10-15 years of progressive IT experience
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
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
Excellent communication, leadership, and negotiation skills

Job Responsibility

Oversee the ITSM framework and ensure alignment with ITIL best practices
Lead global IT Service Desk operations
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
Manage the enterprise MDM platform
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
Health care benefits
Retirement plans
Work/life 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
Uncapped sales commissions

Laboratory Operations Supervisor

Responsible for the operation of their laboratory area in accordance with establ...

Location

United States , Social Circle

Salary:

86500.00 - 135960.00 USD / Year

BioLife Plasma Services

Expiration Date

Until further notice

Requirements

Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical, or medical laboratory science, or medical technology, or nursing from an accredited institution
Or have earned an associate degree in a chemical, biological, clinical, or medical laboratory science, or medical laboratory technology, or nursing from an accredited institution
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records
Demonstrate work history of above-average performance and attendance
Excellent interpersonal skills and communication skills, including written, verbal, and oral presentations
Result-oriented with the ability to adapt to changing priorities
Attention to detail and organizational skills with analytical and problem-solving skills
Proficiency in the use of personal computers and software programs, including Microsoft Word, Excel, and PowerPoint
Ability to stand up for 6-8 hours
Ability to lift, carry, and pull up to twenty-five (25) pounds

Job Responsibility

Provides day-to-day supervision of all laboratory operations and moderate or high complexity testing performance in their laboratory area
Functions as a supervisor for testing personnel performing high and moderate complexity testing
Organize and prioritize workloads and assignments in conjunction with donor center requirements
Responsible for maintaining reagent and consumable inventory
Performs annual employee performance reviews and employee counseling
Performs and reviews pre-analytical staff training and competency assessments
Ensures proper training is received under the oversight of the Operations Manager and the CLIA Laboratory Director
Provides technical assistance to staff, operations, and donor centers in laboratory-related issues
Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone, or electronic consultation to resolve technical problems
Performs NCMR, ENC, and CAPA functions

What we offer

Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time per calendar year
Up to 120 hours of paid vacation (new hires)

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

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

Director, Digital Enablement Operations & Back Office

As the Digital Enabler for Innovation and Operations, you will be a pivotal tran...

Location

United States , Carmel

Salary:

130000.00 - 197000.00 USD / Year

Belden, Inc

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in Engineering, Computer Science, Business, or a related discipline
Proven track record of leading digital transformation initiatives in either a product innovation/R&D or a manufacturing/supply chain environment
Business-Anchored Thinker: Ability to connect digital initiatives to measurable improvements in both innovation (e.g., faster time-to-market, higher innovation ROI) and operations (e.g., efficiency, cost, quality, resilience)
Deep Process Empathy: Demonstrates a strong understanding of the challenges and opportunities within both R&D/engineering and shop floor/supply chain environments
Data-Driven Storyteller: Translates complex analytics and AI insights into actionable recommendations for both technical and non-technical stakeholders
Adoption Champion: Focuses relentlessly on user enablement, habit-building, and continuous improvement to ensure technology is not just launched, but deeply embedded in daily workflows
Collaborative Influencer: Exceptional ability to build strong, cross-functional relationships to drive alignment and accelerate innovation and operational outcomes
Experience with core enterprise platforms such as PLM (Product Lifecycle Management), MES (Manufacturing Execution Systems), IoT, and advanced analytics tools

Job Responsibility

Develop and Execute a Unified Digital Strategy: Design and implement a holistic digital and multi-year roadmap for both innovation and operations, ensuring tight alignment with overarching business and technology objectives
Drive End-to-End Process Digitalization: Lead the digitalization of critical workflows across the value chain, including R&D, product requirements management, simulation, production scheduling, inventory management, and supplier collaboration
Own and Advance Key Digital Platforms: Own the backlog, delivery, and continuous improvement of key innovation and operational platforms (e.g., PLM, MES, IoT, Analytics, CRA Platform), ensuring they meet the evolving needs of the business
Deliver Advanced Analytics and AI-Driven Insights: Partner with data teams to deliver actionable insights for both R&D (e.g., portfolio analysis, predictive project risk) and Operations (e.g., demand forecasting, predictive maintenance, supply chain risk analysis)
Champion Enterprise-Wide Digital Adoption: Act as the primary champion for the adoption of digital tools and platforms across R&D, product, manufacturing, and supply chain teams, ensuring high user-engagement and measurable impact on key business metrics
Lead Comprehensive Change Management: Drive change management, training, and upskilling initiatives for all associated teams to maximize digital adoption, build user self-sufficiency, and realize the full value of technology investments
Foster Cross-Functional Collaboration: Partner with leaders in Data Strategy, AI, Product Management, Engineering, Manufacturing, and Supply Chain to enable seamless digital collaboration and knowledge sharing across the entire product and operational lifecycle
Govern and Measure Performance: Jointly own innovation and operational KPIs and digital adoption metrics with business leaders, ensuring that digital initiatives deliver tangible results against business goals

What we offer

health/dental/vision
long term/short term disability
life insurance
HSA/FSA
matching retirement plans
paid vacation
parental leave
employee stock purchase plan
paid leave for volunteer work in your community
training opportunities

Fulltime

Director, Diagnostics

This Diagnostic Lead role will implement Dx development GSK Development wide enc...

Location

United States; United Kingdom , Collegeville; Stevenage; Waltham; Upper Providence

Salary:

189750.00 - 316250.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Ph.D. in Biological Sciences and 5 years of pharmaceutical and/or diagnostic industry experience or B.S or M.S. with 7 years of pharmaceutical and diagnostic industry experience
Experience in drug / diagnostic development especially late stage development, regulatory approval and life cycle management (eg follow on Dx)
Experience with technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies)
Experience in IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements
Experience performing due diligence and audit of Dx developers
Experience with GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
Experience with QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations
Experience with clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management)
Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as MS Teams

Job Responsibility

Manage the team of associate directors, diagnostics. Team manager to deliver on the vision of equipping GSK to be a leader in oncology through Dx development driving the portfolio value
Monitor and report projects progress, outcomes, KPIs eg delivery of Target Diagnostic Profile
Remove barriers to Dx strategy development and implementation, collaborating cross functionally with clinical operations, external engagement, procurement, etc…
Exhibits timely management and delivery of projects/work streams within agreed budget
Must be able to manage multiple projects and work streams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team’s objectives
Clearly and concisely report project progress and outcomes, coordinating with project management, finance and business operations
Ensure learnings and best practices are shared and adopted for effective delivery
Participate in the evaluation of advanced technologies for IVD and clinical biomarker development
Keep a pulse on team execution and cross-functional ways of working with clinical, regulatory, operations, policy, BD and business unit colleagues and key leadership within project teams
Provides frequent project status updates / reports related to Dx deliverables

What we offer

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Fulltime

New

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

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

Select Country

Associate Director, Manufacturing Science and Technology

Apogee Therapeutics

Location:
United States

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
January 11, 2026

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