Communicate and coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and ... Work closely with your Analytical Development colleagues and external CROs/CMOs collaborators to ...
Communicate and coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and ... Work closely with your Analytical Development colleagues and external CROs/CMOs collaborators to ...
Select, qualify, and manage contract research, development, manufacturing, and testing ... Represent analytical CMC in program and project-team meetings and collaborate closely with Process ...
Select, qualify, and manage contract research, development, manufacturing, and testing ... Represent analytical CMC in program and project-team meetings and collaborate closely with Process ...
Recruit, manage, train, motivate, develop, and mentor Analytical Development staff * Provide leadership, direction, and resource allocation for analytical development activities to ensure achievement ...
Recruit, manage, train, motivate, develop, and mentor Analytical Development staff * Provide leadership, direction, and resource allocation for analytical development activities to ensure achievement ...
Director, Analytical Development
Cambridge, MA · On-site
$185K - $240K/yr
Recruit/manage/train/mentor Analytical Development staff. * Lead analytical development and method transfer to support iPSC expansion/differentiation in GMP manufacturing across the product lifecycle.
Director, Analytical Development
Cambridge, MA · On-site
$185K - $240K/yr
Recruit/manage/train/mentor Analytical Development staff. * Lead analytical development and method transfer to support iPSC expansion/differentiation in GMP manufacturing across the product lifecycle.
Director, Analytical Development
Boston, MA · On-site
$180K - $252K/yr
Lead, develop, and manage a multidisciplinary technical team, including resource planning ... Collaborate with Analytical Development leaders and cross-functional partners to ensure analytical ...
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Director, Analytical Development
Boston, MA · On-site
$180K - $252K/yr
Lead, develop, and manage a multidisciplinary technical team, including resource planning ... Collaborate with Analytical Development leaders and cross-functional partners to ensure analytical ...
Analytical Development Senior Scientist
Boston, MA · On-site
$122K - $183K/yr
Excellent organizational, project management, written, and verbal communication skills .Ability to ... D. with 2+ years or Master's degree with 5+ years of relevant analytical development experience.
Analytical Development Senior Scientist
Boston, MA · On-site
$122K - $183K/yr
Excellent organizational, project management, written, and verbal communication skills .Ability to ... D. with 2+ years or Master's degree with 5+ years of relevant analytical development experience.
Scientist, Analytical Development
Tustin, CA · On-site
$109K - $137K/yr
In the Scientist, Analytical Development role you will have the opportunity to focus on developing ... This position offers the chance to interface with Project Management, Process Development, Quality ...
Scientist, Analytical Development
Tustin, CA · On-site
$109K - $137K/yr
In the Scientist, Analytical Development role you will have the opportunity to focus on developing ... This position offers the chance to interface with Project Management, Process Development, Quality ...
Director, Analytical Development - SMTD
Indianapolis, IN · On-site
$118K - $197K/yr
Provide scientific and operational direction for analytical development projects from early-stage ... Demonstrated experience managing external partnerships, such as contract research organizations ...
Director, Analytical Development - SMTD
Indianapolis, IN · On-site
$118K - $197K/yr
Provide scientific and operational direction for analytical development projects from early-stage ... Demonstrated experience managing external partnerships, such as contract research organizations ...
Senior Director, Analytical Development CMC
Boston, MA · On-site
$165K - $250K/yr
Lead analytical strategy related to phase-appropriate method development, validation, and product ... Excellent project management, organizational, and prioritization skills in fast-paced, multi ...
Senior Director, Analytical Development CMC
Boston, MA · On-site
$165K - $250K/yr
Lead analytical strategy related to phase-appropriate method development, validation, and product ... Excellent project management, organizational, and prioritization skills in fast-paced, multi ...
Partner with Drug Substance, Drug Product, Regulatory Affairs, Quality Assurance, Manufacturing, Project Management, and Research functions to advance development programs. * Serve as analytical ...
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Partner with Drug Substance, Drug Product, Regulatory Affairs, Quality Assurance, Manufacturing, Project Management, and Research functions to advance development programs. * Serve as analytical ...
Scientist, Analytical Development
$109K - $137K/yr
In the Scientist, Analytical Development role you will have the opportunity to focus on developing ... This position offers the chance to interface with Project Management, Process Development, Quality ...
Scientist, Analytical Development
$109K - $137K/yr
In the Scientist, Analytical Development role you will have the opportunity to focus on developing ... This position offers the chance to interface with Project Management, Process Development, Quality ...
Position Overview FCDI is seeking a Senior Analytical Development Scientist to support the company ... Strong problem-solving skills, with demonstrated ability to manage multiple technical projects ...
Position Overview FCDI is seeking a Senior Analytical Development Scientist to support the company ... Strong problem-solving skills, with demonstrated ability to manage multiple technical projects ...
Experience Minimum of 10 years of relevant experience with at least 5 years of management ... Demonstrated expertise in analytical method development including but not limited to potency assays.
Experience Minimum of 10 years of relevant experience with at least 5 years of management ... Demonstrated expertise in analytical method development including but not limited to potency assays.
... project management to support clients. Essential Duties and Responsibilities: * Leads Analytical Development activities to support projects for various modalities, serving as the technical lead and ...
... project management to support clients. Essential Duties and Responsibilities: * Leads Analytical Development activities to support projects for various modalities, serving as the technical lead and ...
Establish and maintain project plans, timelines, budgets, and resource/capacity plans; manage ... Small molecule analytical development across the lifecycle (discovery through commercial ...
Establish and maintain project plans, timelines, budgets, and resource/capacity plans; manage ... Small molecule analytical development across the lifecycle (discovery through commercial ...
Partner effectively with cross-functional teams to define analytical plans, meet project timelines ... Manage inventory of reagents, standards, and consumables; initiate procurement, track critical ...
Partner effectively with cross-functional teams to define analytical plans, meet project timelines ... Manage inventory of reagents, standards, and consumables; initiate procurement, track critical ...
Development Project Manager
$125K - $150K/yr
Independently manage assigned development projects, including scope, budget, schedule, due ... Analyze zoning, municipal codes, permitting, and entitlement requirements and serve as a key ...
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Development Project Manager
$125K - $150K/yr
Independently manage assigned development projects, including scope, budget, schedule, due ... Analyze zoning, municipal codes, permitting, and entitlement requirements and serve as a key ...
Manager, Analytical R&D
Chantilly, VA · On-site
$100K - $130K/yr
... as required for Analytical R&D activities. * Prepare and review SOPs, protocols, reports, to ... Use project management techniques to identify, develop and maintain planning tools (e.g ...
Manager, Analytical R&D
Chantilly, VA · On-site
$100K - $130K/yr
... as required for Analytical R&D activities. * Prepare and review SOPs, protocols, reports, to ... Use project management techniques to identify, develop and maintain planning tools (e.g ...
Development Project Manager
Oak Brook, IL · On-site
$125K - $150K/yr
Independently manage assigned development projects, including scope, budget, schedule, due ... Analyze zoning, municipal codes, permitting, and entitlement requirements and serve as a key ...
Development Project Manager
Oak Brook, IL · On-site
$125K - $150K/yr
Independently manage assigned development projects, including scope, budget, schedule, due ... Analyze zoning, municipal codes, permitting, and entitlement requirements and serve as a key ...
Provide regular updates to management on projects * Identify opportunities for process improvements and propose solutions * Identifies out of trend data. * Responsibilities may increase in scope to ...
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Provide regular updates to management on projects * Identify opportunities for process improvements and propose solutions * Identifies out of trend data. * Responsibilities may increase in scope to ...
Project Manager Analytical Development information
See salary details
$43K - $52K
2% of jobs
$52K - $61K
5% of jobs
$61K - $70K
10% of jobs
$76.8K is the 25th percentile. Wages below this are outliers.
$70K - $79K
11% of jobs
$79K - $88K
15% of jobs
The median wage is $91.7K / yr.
$88K - $97K
18% of jobs
$105.7K is the 75th percentile. Wages above this are outliers.
$97K - $106K
15% of jobs
$106K - $115K
10% of jobs
$115K - $124K
6% of jobs
$124K - $133K
5% of jobs
$133K - $142K
3% of jobs
$43K
$94.5K
$142K
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Director, Analytical Development
Remote
Full-time
Re-posted 9 days ago
Job description
Responsible for managing the development and tracking of stage-appropriate testing methodology for drug substance and drug product, including in-process, release, stability, method validation and site transfer under aggressive timelines. Communicate and coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and consultants, as well as with external CROs/CMOs counterparts. Manage critical analytical review of SOPs, test methods and specifications for raw materials/intermediates/drug substance/drug product, development/verification reports, validation protocols/reports, method transfers, COAs and stability summaries. Support contractor site investigations pertaining to OOS/OOT and deviations.
ResponsibilitiesSupport Analytical (CMC) activities associated with the formulation of infigratinib.
Work closely with your Analytical Development colleagues and external CROs/CMOs collaborators to rapidly advance programs to key decision points, in preparation of regulatory submission, approval and post-approval commitments.
Assist in data generation and analysis.
Ensure analytical development activities are aligned with the project's overall objectives.
Assist in regulatory filings.
Perform data review & stability tracking.
Where You'll WorkRemote with 30% travel anticipated
Who You AreMS in Organic Chemistry, Analytical Chemistry, Pharmaceutical Science.
5+ years' experience in the contract research or pharmaceutical/biotech industry.
Demonstrated abilities in the development and application of analytical assay, impurity, and in-vitro (dissolution) release.
Experience in high performance liquid chromatography and physicochemical properties (solubility, solid state, physical testing), methods development, drug substance and drug product
Knowledge of cGMP regulations, including compendial (USP, EP, JP) and guidance documents.
Working knowledge of FDA, EMA and ICH guidelines.
About BridgeBio
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
201 - 500 Employees
Headquarters location
Palo Alto, CA, US
Year founded
2014