Assoc Director or Director, Process Development
2 weeks ago
PositionSummary:
Reporting to the Executive Director, Process Development and Manufacturing, the Associate Director or Director, Process Development and Manufacturing is responsible for the design and execution of experiments to support process development and provides technical oversight of contract development and manufacturing organizations (CDMOs) for small molecule programs ranging from research phase to clinical development and eventually commercial production. The Associate Director or Director takes a drug substance lead role on one or more programs and manages projects independently.
Essential Duties and Responsibilities:
Design, develop, and implement robust chemical synthesis processes for starting materials, intermediates, and APIs for research and development programs
Support technical transfer of starting material, intermediate, and API processes between sites as needed
Collaborate with medicinal chemistry team during lead optimization and candidate selection phases
Manage and mentor junior scientists and support their professional development
Function as a highly effective communicator and team player in a dynamic team culture
Perform phase appropriate process R&D to support both early stage and late stage programs
Perform fate and purge studies, mutagenic impurity evaluation and establish the framework for the control strategy of the drug substance from early development with a long-term vision of the commercial process
Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and vendors
Critical review of proposals from CMOs and CROs; perform appropriate due diligence as needed to ensure CMOs and CROs can support the requirements of individual chemical development programs effectively
Support PAR studies and pre-validation and validation activities for drug substance
Author relevant CMC sections for US and ex-US regulatory filings as needed
Up to 25% travel for scientific project management and monitoring of critical project activities
Perform all duties in keeping with the Company’s core values, policies and all applicable
regulations
Required Education, Experience
and Attributes
:
PhD in synthetic organic chemistry with a minimum of 10 years of industry experience developing small molecule pharmaceuticals
Laboratory experience in synthetic organic chemistry and small molecule process development required
Chemical development experience with synthesis and crystallizations of chiral molecules preferred
Thorough understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization and patent protection
Thorough understanding of cGMP, ISO, and ICH guidelines and industry best practices
Experience and understanding of Design of Experiments (DOE) and Quality by Design (QbD) principles
Experience managing and overseeing development and manufacturing activities at CDMOs
Ability to build strong relationships with co-workers of various backgrounds and expertise; flexibility and integrity are both paramount
Ability to function at a high level in a team setting whether as manager, lead scientist, or individual contributor
Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced
environment
Effective interpersonal and communication skills; a collaborative team player with a can-do attitude
, desire to pitch in where and when needed,
and the ability to
identify
and implement creative solutions to complex technical
problems
Strong learning orientation, curiosity, and passion for science and patients
ADA Notation:
In this work environment, the employee is occasionally exposed to moving mechanical parts, unpleasant odors, and loud noises. Interaction with laboratory equipment, samples, supplies, and laboratory personnel may be
required
whereby
appropriate precautions
are to be taken per the Company’s Safety and Injury, Illness and Prevention Plans.
The
anticipated
salary
range
for
this position
is
$180,000 to $220,000.
The
final
salary
offered
to
a
successful
candidate
will
be
dependent
on
several
factors
that
may
include
but
are
not
limited
to
the
type
and
length
of
experience
within
the
job,
type
and
length
of
experience
within
the
industry,
education,
etc
etera.
In addition to base salary,
the
h
ired applicant will be eligible to receive
an
annual bonus and an equity grant at hire and annually in the form of
the
option to purchase stock in the future for a specified price.
#J-18808-Ljbffr
-
Assoc Director or Director, Process Development
1 month ago
South San Francisco, United States Erasca, Inc. Full timeErasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide....
-
Director of Development
3 weeks ago
San Francisco, United States Cathedral School for Boys Full time**Role Title**: Director of Development **FLSA Status**: Exempt **Reports to**: Head of School **Direct Reports**: Manager of Annual Giving and Events, Database and Development Associate **Main Purpose of the Role**: The Director of Development works closely with the Head of School and the Board of Trustees and supervises a small team to provide...
-
South San Francisco, California, United States IDEAYA Biosciences Full timeWe are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development...
-
Development Director
3 weeks ago
San Francisco, United States St. Vincent de Paul Society of San Francisco Full timeDirector of Development Exempt/Full Time Salary Range: $115,000.00 To 130,000.00 Annually Location: San Francisco Reports to: Executive Director ORGANIZATIONAL OVERVIEW The St. Vincent de Paul Society of San Francisco (SVDP-SF) is dedicated to providing hope and direct person-to-person assistance to break the cycles of homelessness and domestic violence....
-
Development & Communications Director
2 weeks ago
San Francisco, United States Lavender Youth Recreation & Information Center (LYRIC) Full time**Position Title**: Development & Communications Director **Position Type**: Full-time (40 hours per week), Exempt **Reports to**: Executive Director/President **About LYRIC** Founded in 1988, the Lavender Youth Recreation & Information Center (LYRIC) provides support and services to nearly 2,000 lesbian, gay, bisexual, transgender, queer, questioning...
-
Development Director
3 weeks ago
San Francisco, United States St. Vincent de Paul Society of San Francisco Full timeDirector of Development Exempt/Full Time Salary Range: $115,000.00 To 130,000.00 Annually Location: San Francisco Reports to: Executive Director ORGANIZATIONAL OVERVIEWThe St. Vincent de Paul Society of San Francisco (SVDP-SF) is dedicated to providing hope and direct person-to-person assistance to break the cycles of homelessness and domestic violence....
-
Development Director
3 weeks ago
San Francisco, United States St. Vincent de Paul Society of San Francisco Full timeDirector of Development Exempt/Full Time Salary Range: $115,000.00 To 130,000.00 Annually Location: San Francisco Reports to: Executive Director ORGANIZATIONAL OVERVIEW The St. Vincent de Paul Society of San Francisco (SVDP-SF) is dedicated to providing hope and direct person-to-person assistance to break the cycles of homelessness and domestic...
-
Development Director
3 weeks ago
San Francisco, United States St. Vincent de Paul Society of San Francisco Full timeDirector of Development Exempt/Full Time Salary Range: $115,000.00 To 130,000.00 Annually Location: San Francisco Reports to: Executive Director ORGANIZATIONAL OVERVIEWThe St. Vincent de Paul Society of San Francisco (SVDP-SF) is dedicated to providing hope and direct person-to-person assistance to break the cycles of homelessness and domestic violence....
-
Director/Sr. Director Process Engineering
1 month ago
San Francisco, United States Nobell Foods Full timeNobell Foods is creating cheese and other dairy products from plant-derived dairy proteins for the 99% of people who are unwilling to compromise on taste and price. Nobell is made up of a team of passionate scientists, explorers, and storytellers on a mission to radically change the way we make food, so it’s better for you, the animals, and the planet. We...
-
Development Director
4 weeks ago
San Francisco, United States ST VINCENT DE PAUL SOCIETY OF SAN FRANCISCO Full time**_Life changing work_**_ _**_* Welcoming staff - Generous benefits - Advancement opportunities_** **Join the St. Vincent de Paul Society of San Francisco and be part of the solution to break the cycles of homelessness and domestic violence in San Francisco**. - . - St. Vincent de Paul Society of San Francisco operates the Multi-Service Center - Northern...
-
Director of Development
1 month ago
San Francisco, United States Anti-Defamation League Full timeOverview: POSITION TITLE: Director of Development REPORTS TO: Director of Philanthropic Outreach SUPERVISION EXERCISED: Associate Director of Development LOCATION: San Francisco, California Grade/Class: Grade I, Exempt, PSA-Eligible ABOUT THE ORGANIZATION: ADL is the leading anti-hate organization in the world. Founded in 1913, its timeless mission is to...
-
Director of Development
2 weeks ago
San Francisco, United States Equal Rights Advocates Full timeThe Director of Development is a senior leader of the growing Equal Rights Advocates (ERA) team who will manage ERA's Development team and lead Equal Rights Advocates' fundraising goals to meet its $4.3 million operating budget and substantially grow revenue over the next three years. The Director of Development, in close collaboration with the Executive...
-
Director of Development
1 month ago
San Francisco, United States Cathedral School For Boys Full timeMain Purpose of the Role The Director of Development works closely with the Head of School and the Board of Trustees and supervises a small team to provide leadership for the Development program as it builds a strong culture of philanthropy throughout the School and global community. The goal of the Director of Development is to design programs of giving...
-
Director of IP Development
1 month ago
San Francisco, United States Targeted Talent Full timeJob Description Job Description Director of IP Development Join us in propelling our client’s organization forward as we seek an accomplished Director of IP Development, poised to guide a dynamic team of engineers in crafting essential IPs integral to their forthcoming AI acceleration SOC. In this influential role, the Director will be entrusted with the...
-
Business Development Director, RMS
3 weeks ago
South San Francisco, California, United States Charles River Laboratories Full timeBusiness Development Director, RMS (SF/Bay Area) Req ID #: Location: South San Francisco, CA, US, 94080San Francisco, CA, US, 94158Wilmington, MA, US, 01887S. San Francisco, CA, US, 94080 For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you...
-
Senior Medical Director, Clinical Development
3 weeks ago
South San Francisco, United States Sonoma Biotherapeutics Full timeAbout Sonoma Biotherapeutics: Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next-generation genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum...
-
Senior Medical Director, Clinical Development
1 month ago
South San Francisco, United States Sonoma Biotherapeutics Full timeAbout Sonoma Biotherapeutics:Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next-generation genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum of...
-
Senior Medical Director, Clinical Development
1 month ago
South San Francisco, United States Sonoma Biotherapeutics Full timeAbout Sonoma Biotherapeutics:Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive Treg therapies cell for autoimmune and degenerative diseases. Using next-generation genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum of...
-
South San Francisco, United States Clinical Dynamix Full timeTitle: Director, GSPV Operations, Process, Quality, and Compliance Reports to: Vice President, Global Safety and Pharmacovigilance Location: Remote Position Position Overview The Director Global Safety and Pharmacovigilance (GSPV) Operations, Process, Quality and Compliance i s responsible for the establishment, maintenance and oversight of appropriate...
-
South San Francisco, United States Ethical Search Professionals Full timeDirector, GSPV Operations, Process, Quality, and Compliance Apply Location South San Francisco, CA Full Remote Title: Director, GSPV Operations, Process, Quality, and Compliance Reports to: Vice President, Global Safety and Pharmacovigilance Location: Remote Position Position Overview The Director Global Safety and Pharmacovigilance (GSPV) Operations,...
