-
Lead Project Cost Estimator
1 week ago
Lee Andrews Group, Inc. Los Angeles, United StatesWe are looking for a Lead Project Cost Estimator for a position on a school district new construction and modernization bond program. · **DUTIES**: · - Leads and supervises a team of Estimators, including designating daily assignments. · - Plans and participates in the preparatio ...
-
Lead Project Cost Estimator
1 week ago
KKCS Los Angeles, United States**WHO IS KKCS** · Kal Krishnan Consulting Services, Inc. (KKCS), a California Corporation, is a full-service construction management and program management organization. The firm has grown steadily in size and capability since its founding in 1987, and today employs more than 85 ...
-
Lead Project Cost Estimator
2 days ago
Pacifica Services Los Angeles, United States**Duties**: · - Leads and supervises a team of Estimators, including designating daily assignments · - Plans and participates in the preparation of construction cost estimates of buildings or other structures from drawings, outlines, and specifications · - Prepares and reviews co ...
-
Lead Project Cost Estimator
1 week ago
Cordoba Corporation Los Angeles, United StatesOverview: · **Lead Project Cost Estimator - Education** · **Responsibilities**: · - Leads and supervises a team of estimators, including designating daily assignments · - Plans and participates in the preparation of construction cost estimates of buildings or other structures fro ...
-
Project Lead
1 week ago
Nexus Dynamics Golden Acres, United StatesGolden Acres is seeking a candidate with experience in managing large IT and technology programs and teams. Candidates with experience in managing OCR technologies and Automation programs will be highly valued. Additionally, candidates with managerial experience in machine learni ...
-
Project Lead
1 week ago
Archinect Los Angeles, United StatesG Charles Design is a design office located in Reseda. Our internal structure is based on a design studio in a traditional setting with a team of 8 staff to 1 principal licensed architect. We are offering project lead positions where our architecture business model is based on ex ...
-
Project Lead
1 week ago
GPAC Los Angeles, CA, United StatesSEEKING COMMERCIAL PAINT PROJECT MANAGER GPAC: #1 Commercial Paint Recruiting Firm in North America: WORK FOR A LEADING CONTRACTOR · I am currently collaborating with several highly regarded and firmly established Commercial Paint Contractors, I'm on the lookout for experienced ...
-
Project Lead
1 week ago
We Tidy Garages Los Angeles, United StatesJob Description · Job Description · About Us: · We Tidy Garages is a fast-growing home and garage organization company. We not only work with clients to clean, declutter, and organize their spaces but also to list and sell their unwanted items on e-commerce resale platforms. · ...
-
Project Lead
5 days ago
JT4 Los Angeles, United States Full timeJT4 is hiring a Project Schedule Manager/Project Lead for their Edwards AFB located in California. · JT4, LLC provides engineering and technical support to multiple western test ranges for the U.S. Air Force, Space Force and Navy under the Joint Range Technical Services Contract, ...
-
Project Lead
4 days ago
We Tidy Garages Los Angeles, United StatesJob Description · Job DescriptionAbout Us: · We Tidy Garages is a fast-growing home and garage organization company. We not only work with clients to clean, declutter, and organize their spaces but also to list and sell their unwanted items on e-commerce resale platforms. · Why ...
-
Project Management Lead
1 week ago
Elephant Los Angeles, United StatesElephant is looking for an efficient, organized Project Management Lead to manage large-scale interactive projects from project conception and planning through implementation and delivery. Project Management Leads at Elephant are ready to strategically prioritize project delivera ...
-
Project Management Lead
2 weeks ago
Elephant Los Angeles, United StatesElephant is looking for an efficient, organized Project Management Lead to manage large-scale interactive projects from project conception and planning through implementation and delivery. Project Management Leads at Elephant are ready to strategically prioritize project delivera ...
-
Lead Project Manager
1 week ago
Circle Los Angeles, United StatesCircle is a financial technology company at the epicenter of the emerging internet of money, where value can finally travel like other digital data — globally, nearly instantly and less expensively than legacy settlement systems. This ground-breaking new internet layer opens up p ...
-
Facilities Construction Project Lead
1 day ago
The Aerospace Corporation El Segundo, United StatesThe Aerospace Corporation is the trusted partner to the nation's space programs, solving the hardest problems and providing unmatched technical expertise. As the operator of a federally funded research and development center (FFRDC), we are broadly engaged across all aspects of s ...
-
Lead Project Cost Estimator
1 week ago
ARCADIS Los Angeles, United StatesJob Description · Arcadis is seeking a Lead Project Cost Estimator to support our Places infrastructure group in Los Angeles, CA. This position is a client site based position. · Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy ...
-
Lead Project Cost Estimator
4 days ago
KKCS Los Angeles, United StatesIf you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.Regular Full-Time Professional Los Angeles, CA, US2 days ago Requisition ID: 1276Salary Range: $175,900.00 To 180,900.00 Ann ...
-
Lead Project Cost Estimator
1 week ago
Element Consulting, Inc. Los Angeles, United StatesDuties: Leads and supervises a team of Estimators, including designating daily assignments · Plans and participates in the preparation of construction cost estimates of buildings or other structures from drawings, outlines, and specifications · Prepares and reviews cost estimat ...
-
Lead Project Cost Estimator
3 days ago
Cordoba Los Angeles, United StatesOverviewLead Project Cost Estimator - EducationCordoba is seeking a Lead Project Cost Estimator to support its Education Sector. This role assists the Chief Estimator by supervising a team of estimators, planning and participating in construction cost estimates, securing funding, ...
-
Lead Project Cost Estimator
4 days ago
Hill International Los Angeles, United StatesJob Description · Hill International is seeking a Lead Project Cost Estimator in Los Angeles, California · ResponsibilitiesLeads and supervises a team of Estimators, including designating daily assignments · Plans and participates in the preparation of construction cost estimate ...
-
Lead Project Cost Estimator
5 days ago
Vanir Construction Management Los Angeles, United StatesAbout Vanir: · Vanir has been exceeding client expectations since 1964. Our progressive growth and quality of service has led Vanir to become consistently ranked among the top construction management firms in the nation by Engineering News-Record. As we continue growing into new ...
Tech Transfer Project Lead - Los Angeles, United States - Softworld A Kelly Company
Description
Job Title:
Tech Transfer Project LeadLocation: San Francisco CA 94107 Remote
Job Description:
The Tech Transfer Project Lead, Drug Substance Development and Manufacturing will oversee key scientific, regulatory, and business functions pertaining to process chemistry for the organization.
Responsibilities include oversight of late development/launch preparation activities including (but not limited to): the development of chemical processes for active pharmaceutical ingredients (APIs) and regulatory starting materials (RSMs), process scale-up, technology transfer, and validation of chemical processes.
Effective management of CROs and CMOs will be a key strategy and activity required to accomplish the functions mentioned.The position will also contribute to overall strategy and authoring of Module 3 drug substance sections of regulatory submissions by provision of required scientific data and document review.
Responsibilities:
Proven leadership experience in managing drug substance development teams at various experience levels internally (direct report mgmt.) and externally (CRO/CMO mgmt.)Manage multiple CMOs/CROs to deliver final bulk active drug substance (incl.
Create and disseminate technical transfer information and documents required by CROs/CMOs to develop and scale up chemical processes and develop analytical methods.
Establish and maintain business relationships with CROs and CMOs appropriate for performing process development requirements.Compose key terms for/review/execute contracts with, and manage the activities of, CROs/CMOs required to deliver process development tasks on time and within established budgets.
Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controls.Ensure that CRO/CMO activities and other process development activities address drug substance needs for pharmaceutical formulation development, toxicology testing, clinical trials, and commercial launch.
Ensure that all chemical processes are developed to deliver on company targets of cost, quality, safety, environmental, and operability needs.
Maintain a working knowledge of manufacturers and suppliers of chemical raw materials, reagents, and intermediates capable of addressing the process requirements of the company in a timely and economical manner.
Identify and lead key process problem resolution activities and process improvement initiatives.Lead scale-up, process development, process engineering, and finalization (validation) of process for commercial-scale manufacturing.
Extract scientific data and provide appropriate document review to support regulatory filings and commercialization in a timely manner.
Create a culture of continuous improvement and high-performance teamwork.
Continually seek and implement process development best practice methodologies.
Work closely with QA function to develop and operate to appropriate CMC procedures, and to ensure the product meets established quality standards.
Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD.Expected to contribute to the overall regulatory strategy for the encaleret program (responsible for DS and consulted for DP strategy)Preference will be given to candidates with prior NDA/MAA authoring experience.
Prior NCE filing experience a plus.Education, experience & skills requirements:
Minimum of Ph.
D.
(ideally chemistry, chemical engineering) with 7+ years relevant experience, or BS/MS with 10+ years relevant experienceDemonstrated experience in managing API chemical development, process validation, and manufacturing in support of NDA marketing applications and commercial production.
Demonstrated track record of delivering drug substance candidate(s) into chemical manufacturing and commercialization.Demonstrated chemistry development at an industrial scale.
Significant project leadership experienceStrong aptitude and demonstrated experience in synthetic organic chemistry.
Working knowledge of modern analytical separation techniques pertaining to the separation/purification of organic compoundsWorking knowledge of analytical methods development and validationFamiliarity with FDA and ICH guidelines for INDs/NDAs/MAAs and cGMPsThis position will also require a thorough understanding of cGMP, quality, and regulatory requirements, including the preparation and writing of key sections of regulatory documents (such as NDAs, MAAs, and INDs)Experience in managing CMOs, scientific collaborations, and contracted R&DAbility to effectively interface with and/or manage highly skilled internal staff.
Training and education in organic synthesisWorking knowledge of process economicsAbility to work independently as well as in a team; ability to build good work relationships.
Strong attention to detail and time management skillsExcellent oral and written communication skills#J-18808-Ljbffr