Associate Director, Analytical Development and Quality Control Job at Kailera Therapeutics (Waltham)

Associate Director, Quality Control – Analytical Sciences

We are seeking an Associate Director to join the QC Analytical Sciences team in ...

Location

United States

Salary:

165000.00 - 185000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)
7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)
Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology
Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation
Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections
Excellent communication skills with an ability to collaborate effectively across functional lines
Ability to work independently and multi-task in a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

Job Responsibility

Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations
Partner with global and cross-functional teams to ensure successful implementation of harmonized methods
Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements
Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues
Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines
Generate and review technical documents, including protocols, reports, and method lifecycle documents

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

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

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. Manages the batch review and release activities
Fulfills the role of PRRC, specific to: Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release
Ensuring Post-Market Surveillance (PMS) obligations are met
Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department. Manage regulatory inspections
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Associate Director, Product Quality Assurance

The Associate Director of Product Quality for Cell and Gene Therapy Programs wil...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in scientific discipline
12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role
Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements
Ability to influence without direct authority
Ability to develop into a primary PQL for Beam programs
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Excellent listening, communication and interpersonal skills fostering team spirit

Job Responsibility

Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments
Drives and takes action on Phase Appropriate Quality strategy for Beam’s products
Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation
Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc
Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL
Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives
Support clinical to commercial analytical control strategy
Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.)
Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations

Fulltime

Associate Director, Strategic Sourcing, Commercial and G&A

Beam is seeking an experienced procurement leader to oversee end-to-end indirect...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree in finance, Accounting, Economics, Business or a related field
7-10 years of progressive experience in Strategic Sourcing, Category Management, or Procurement leadership within biotechnology, pharmaceutical, or regulated industries
Demonstrated experience supporting Commercial organizations in a life sciences environment
Experience managing indirect categories including IT, Professional Services, Marketing, and Corporate Services
Strong process-mapping and process-improvement skills with close attention to detail
High degree of customer focus and demonstrated collaboration in a team environment
Proven success leading complex negotiations and delivering structural cost savings
Strong project management skills, including the ability to prioritize, balance and manage multiple efforts with strong results/goal orientation
Outstanding written and verbal communication skills, with the ability to convey strategies and results to a diverse audience
Able to travel when needed

Job Responsibility

Develop and execute multi-year category strategies aligned to Commercial and enterprise objectives, incorporating spend analytics, market intelligence, and risk assessment
Lead complex RFIs, RFQs, and RFPs and drive end-to-end sourcing lifecycle management, including supplier selection and negotiation strategy development
Negotiate and execute contracts with strategic suppliers and service providers, ensuring alignment with defined KPIs, SLAs, compliance standards, and measurable value delivery
Set strategic direction and own responsibility for all day-to-day purchasing and category management activities, including order accuracy, compliance, and serving as the primary escalation point for commercial and service issues
Serve as a strategic business partner to Commercial, Finance, Quality, IT, and Legal teams
present supplier performance, savings delivery, and risk updates to leadership
Collaborate with Accounts Payable to resolve purchasing discrepancies and strengthen procurement governance and controls
Build and manage strong supplier relationships, establish performance scorecards and dashboards, and conduct structured business reviews to ensure quality, delivery, cost, and service excellence
Anticipate supply market dynamics and mitigate risk through supplier rationalization, contingency planning, and proactive issue resolution to avoid operational disruption
Set strategic directions and responsibility for all day-to-day purchasing activities. Mange orders for completeness, accuracy, and compliance. Act as the initial escalation point for purchasing issues

Fulltime

Associate Director Media - LVL

In this role, you will support the planning, execution, and optimization of Amge...

Location

United States

Salary:

150768.75 - 203981.25 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of media and/or marketing experience OR Masterâ€™s degree and 5 years of media and/or marketing experience OR Bachelorâ€™s degree and 7 years of media and/or marketing experience OR Associateâ€™s degree and 12 years of media and/or marketing experience OR High school diploma / GED and 14 years of media and/or marketing experience
7+ years of experience in paid media/marketing with a focus on planning, buying, execution and measurement
Technical competencies: expert in media targeting and segmentation (consumer and HCP), multi-channel media plan development, omnichannel orchestration and journey planning and execution, media measurement and optimization, agency leadership
Experienced leader of teams, both internal and external
Expertise in media planning and deliveries for traditional/linear/TV as well as digital channels and platforms
Strong analytical skills with an ability to uncover insights from performance/measurement tracking to drive action that increases brand impact
Strong ability in both leading cross-functional teams, and in being a member of a cross-functional team
Skilled communication effectiveness: the ability to effectively engage, connect, and influence senior leadership and marketing organizations
Ability to translate and communicate complex information/strategies into simple and impactful carry out of plans
Desire and ability to find opportunities to work smarter and more efficiently, and implement with excellence

Job Responsibility

Support the execution of media strategy across Digital, Addressable, Video, TV, Search, and Point of Care channels for both HCP and DTC audiences, ensuring alignment to brand and enterprise objectives
Serve as a media subject-matter expert at the brand or portfolio level, advising stakeholders on channel roles, audience strategy, investment mix, and optimization across the customer journey
Manage day-to-day media activation and operations, including trafficking, tagging, tracking, and quality control, ensuring accurate and timely execution across all assigned campaigns
Apply and reinforce enterprise media platform and operational standards (e.g., DCM, Prisma, MediaTools, Guidelines), ensuring consistency, compliance, and data integrity in execution
Partner closely with Analytics and Technology teams to implement measurement frameworks, tagging standards, and tracking methodologies that enable performance reporting and optimization
Manage brand-level agency relationships, setting clear expectations for execution quality, measurement rigor, and operational discipline across planning, buying, and reporting
Support coordination with media platform partners, staying informed on platform capabilities, policy updates, and compliance considerations relevant to pharmaceutical marketing
Enable effective cross-functional collaboration with Brand, Medical, Corporate Communications, Legal, Technology, and Analytics teams to ensure seamless, compliant execution
Identify and support test-and-learn initiatives, including piloting new channels, platforms, data solutions, or activation models
Evaluate pilot results and performance insights, providing recommendations to inform enterprise-level scaling decisions

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Associate Director - Enterprise Risk Management

Location

Ireland , Dublin

Salary:

Not provided

Waystone Governance Ltd.

Expiration Date

Until further notice

Requirements

An internationally recognized professional qualification
Strong academic background including a Degree in Finance/Business/Economics or related field
Experience in enterprise risk, compliance, or process / control auditing ideally within a regulated environment
Strong analytical and critical thinking capability with the ability to synthesise information and identify key risk themes
Demonstrated ability to build effective relationships and work collaboratively across functions and levels of seniority
Proven ability to apply independent judgment with a proactive and pragmatic approach to risk management
Ability to operate effectively in a fast-paced environment managing multiple priorities
Proficient in the use of Power BI for data visualization and risk reporting
Strong attention to detail with a high standard of documentation discipline supported by Strong MS Office skills.

Job Responsibility

Oversee the embedding of the Enterprise Risk Management Framework (ERMF) across the Group including risk identification, assessment, monitoring, escalation and reporting, working closely with first line stakeholders to support effective ownership
Drive the implementation and continuous improvement of the Group’s Control Assurance framework as a core element of the ERMF ensuring clear linkage between risks, controls and assurance activity
Lead the design, rollout and embedding of 1LOD Controls Self-Assessments (CSA) across the Group ensuring consistency of approach, quality of outputs and meaningful risk and control insight
Plan and execute periodic risk based 2LOD testing and assurance activities through the Controls Assurance Assessment Programme (CAAP) assessing both control design and operating effectiveness
Oversee bi-annual Risk Control-Self Assessments for the Core Function teams ensuring robust challenge, consistency of application and alignment with the RMF
Contribute to the ongoing evolution and maturity of the RMF including enhancements to methodologies, standards, tooling and documentation
Design, develop and enhance Risk Management Framework dashboards and risk reporting for senior management, Risk Committees and Boards
Generate clear structured and actionable risk insight within the Enterprise Risk team in particular through Control Assurance testing including CSA, RSCA and CAAP
Build strong relationships across Business Units, Core Functions and jurisdictions acting as a trusted second-line partner
Promote a consistent risk and controls culture across the Group through engagement, communication and training initiatives

Fulltime

Fns associate director

This job description indicates the general nature and level of work expected of ...

Location

United States , Aurora

Salary:

51.05 - 76.60 USD / Hour

Advocate Aurora Health

Expiration Date

Until further notice

Requirements

Certification / License: ServSafe Certification
Education: Bachelor's Degree in Dietetics, hospitality management, business, or related field
Work Experience: 5 years in food service for a large or multi- hospital setting or multi-regional enterprise operations. Including 3 years of management experience in healthcare management.
Knowledge / Skills / Abilities: Ability to establish excellent working relationships and strategic partnerships with various teams, physicians, executives, and other team members across a large organization to active a shared vision, values, and objectives
Results oriented and strong execution skills
Tenacity and attention to detail to effectively evaluate programs
Ability to successfully work in a matrixed organization
Analytical and problem-solving skills, creative facilitation, and innovation in collaboration with leaders across the organization
Skills in consulting, designing/conducting studies, and developing/implementing solutions for issues with significant finical and operational impact on the organization
Knowledge of trends in health care delivery and understanding of health care dynamics within an integrated health care system

Job Responsibility

Monitors that nutritional screening information is obtained, evaluated, and utilized in formulating a patient’s nutritional care plan
Monitors that patients’ menus are checked and corrected against formulated meal patterns and/or diet orders
Monitors that the items on the patients’ trays are consistent with the patient’s medical record, in accordance with departmental standards
Monitors process of tray line assembly, delivery, and temperature of patient foods in Patient Services to ensure food safety and quality
Monitors that patients are educated regarding long term nutritional care through individual discussion and group classes
Monitors that nutritional assessments are performed in accordance with departmental standards
Maintains department records, reports, and files as required
Develops reports and critical analysis as requested for maintenance of efficient department operations
Reviews and maintains nutrition care and tray line policies and practices within current nutrition modalities and in accordance with Accrediting Organization standards
Establishes and initiates procedures and policies to support operations with attention to productivity, safety, and quality

What we offer

Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs
Educational Assistance Program

Fulltime

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Associate Director, Analytical Development and Quality Control

Job Description

Job Responsibility

Requirements

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