- Develop and execute analytical strategies to support the Chemistry, Manufacturing, and Controls aspects of biologics development, ensuring robust analytical methods for product characterization, release testing, and stability studies in compliance with Good Manufacturing Practices (GMP) and ICH guidelines.
- Lead and mentor a team of scientists responsible for method development, validation, and transfer for various analytical techniques pertinent to CMC, including HPLC, mass spectrometry, ELISA, and potency assays, with a strong emphasis on GMP compliance.
- Drive innovation in analytical methodologies and technologies to enhance product characterization, comparability, and process understanding, while ensuring compliance with regulatory expectations and industry best practices for GMP and ICH elements.
- Oversee the qualification and validation of analytical methods for CMC-related activities, including stability-indicating assays, impurity testing, and characterization of critical quality attributes (CQAs), with a focus on meeting regulatory expectations for GMP compliance.
- Act as a subject matter expert on analytical development-related matters within CMC, representing the department in internal meetings, regulatory interactions, and external collaborations related to GMP and ICH elements.
- Establish and maintain relationships with CROs/CMOs for outsourcing analytical testing related to CMC, ensuring timely delivery of high-quality data and results to support manufacturing activities in accordance with GMP requirements.
- Contribute to the preparation of CMC sections for regulatory submissions (IND/BLA), including analytical method validation reports, specifications, and comparability assessments, with a strong focus on meeting GMP and ICH expectations.
- PhD or equivalent degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
- 8+ years of experience in biopharmaceutical analytical development, with a focus on CMC-related activities and a proven track record of success in developing and validating methods for biologics, preferably antibodies, in compliance with GMP and ICH guidelines.
- Demonstrated leadership experience, including managing and mentoring scientific teams, and a strong ability to collaborate effectively across multidisciplinary teams.
- Expertise in a wide range of analytical techniques, instrumentation, and regulatory requirements relevant to CMC in biologics development, with a thorough understanding of GMP and ICH elements.
- Experience with IND/BLA filings and interactions with regulatory agencies (FDA/EMA) related to CMC, with a focus on meeting GMP and ICH expectations, is highly desirable.
- Strong organizational skills, attention to detail, and the ability to thrive in a fast-paced, dynamic environment
-
Vice President Analytical Development
1 week ago
SciPro California, United StatesVice President Analytical Development · This is an opportunity to work the most innovative Biotechs thriving in the San Francisco Bay Area right now. They are actively seeking a VP level expert in Analytical Development to lead their Operations and Analytical Development sectors ...
-
Business Intelligence Analytics Developer
1 week ago
Impresiv Health California, United StatesJob Description · Title: BI Analytics Developer · Duration: Direct hire · **** Please no third party candidates at this time, must be able to work on the clients W2**** · Location: Onsite- Los Angeles, CA · Description: Our client is seeking a BI Analytics Developer to join the ...
-
Scientist II, Analytical Development
2 weeks ago
Astellas California, United StatesDo you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Aste ...
-
EPM Scientific California, United StatesTitle: Head of Analytical Development (Biologics) · Location: California · Overview: · We are seeking a highly experienced and dynamic individual to join our team as the Head of Analytical Development (Biologics). This pivotal role will drive the analytical strategy and execution ...
-
Cloud-Based Data Analytics Developer
4 weeks ago
Gardner Resources Consulting, LLC California, United StatesWe're seeking a motivated individual to drive innovation and contribute to our mission of protecting valuable assets through cutting-edge technology. · What You'll Do: · As a Big Data Cloud-Based Vulnerability Management Data Analytics Developer, you'll be instrumental in designi ...
-
Commercial Purchasing Employee
1 week ago
BlueWave Ventures Albion, United StatesWhat to expect · As part of the central purchasing team at Albion, you will be responsible for handling commercial and administrative processes and act as a competent point of contact for employees, suppliers, and service providers. · Your responsibilities will include obtaining ...
-
Financial Reporting Analyst
3 weeks ago
Mastech Digital California, United StatesPOSITION: Financial Analyst/Financial Reporting (Data Reporting & Analytics) · LOCATION: Remote( Alameda Oakland CA 94612) · DURATION: 24 months, with potential to extend. · Pay: $45-50/hr on W2 · Looking for financial analyst with these skills. · Strong data analytics. · has cr ...
-
Senior Director Marketing Analytics
4 weeks ago
Harnham California, United StatesSENIOR DIRECTOR MARKETING ANALYTICS · $300,000 - $325,000 BASE · LOS ANGELES METRO AREA · HYBRID · An exciting opportunity to join a renowned marketing firm specializing in data-driven marketing solutions to engage customers · THE COMPANY · With a focus on leveraging analytics, t ...
-
Group Director Marketing Sciences
3 weeks ago
Harnham California, United StatesGROUP DIRECTOR MARKETING SCIENCES · $250,000 - $300,000 BASE · LOS ANGELES METRO AREA · HYBRID · An exciting opportunity to join a renowned marketing firm specializing in data-driven marketing solutions to engage customers · THE COMPANY · With a focus on leveraging analytics, thi ...
-
Director Marketing Analytics
4 weeks ago
BrainWorks California, United StatesHealth insurance provider based in California seeks a Senior Manager of Digital and Marketing Analytics. · The Senior Manager of Digital and Marketing Analytics will report to the Senior Director of Customer Experience, Digital, and Operations Analytics · This position can be 100 ...
-
Healthcare Analytics Manager
3 weeks ago
Apree Health California, United States Full timeDescription · Healthcare Analytics Manager · At apree health, our mission is to solve the affordability crisis and empower people to make the best choices for their health and care. We offer a health benefits platform that engages employees to make better healthcare decisions an ...
-
Vice President, Credit Risk Analytics
6 days ago
JCW California, United StatesJCW Group is partnering with a growing regional bank to hire a Vice President of Credit Risk Analytics. This role will be hands on with shaping the firm's risk management strategy and will work to develop and implement advanced analytical models, ensuring that our credit risk pra ...
-
Fashion Marketing Associate, Hybrid
4 weeks ago
24 Seven Talent California, United StatesOur client, a fashion company, is looking for a Marketing Associate to support on a project basis. · Start Date – May through September · 40hrs a week · Pay- appx $35/hr W2 · Appx 2 days on site, IN CARSON, CA · Our client, a fashion ecommerce company, is looking for a Marketin ...
-
Sr Workday HRIS Specialist
4 weeks ago
SystemsAccountants California, United StatesSystemsAccountants is helping a collaborative company recruit a Sr Workday HRIS Specialist, and the remote role comes with an excellent salary and benefits package. · The Sr Workday HRIS Specialist will work closely with the Manager of HR Systems and two Systems Specialists to su ...
-
Director/ Sr. Director, Strategy
1 week ago
EMPIRE California, United StatesSr. Director or Director, Strategy and Data Analytics · EMPIRE is a premier and dynamic music company that prides itself on the development and support of independent artists. We are a rapidly growing firm that has been making waves in the music industry, with an extensive portfo ...
-
Senior Manager Pharma Insights
6 days ago
Smith Hanley Associates California, United StatesTitle: Senior Manager Pharma Insights · Location: Greater Los Angeles Area (on-site) · Compensation: $160-180k + bonus, relo, LTI · Contact: Daniel Wilberschied- · On the hunt for a Senior Manager level position leading insights and analytics for a Global Biopharmaceutical compa ...
-
Manager/Director, Business Intelligence
3 weeks ago
EVCS California, United StatesIMPORTANT: ALL APPLICANTS MUST FILL IN THIS FORM FOR THE APPLICATION TO BE REVIEWED: · Are you interested in electric vehicles and EV charging technologies? Do you enjoy managing and analyzing extensive datasets across various business functions to uncover strategic insights? Do ...
-
Business Intelligence Developer
6 days ago
VIA Technical California, United StatesLength: Around 3 Months (potential to extend through October or longer ) · Remote (with 2-3 days travel to San Diego, CA each month ideally) · W2 Contract Only. · Project: · They have single faceted reporting that they want to bring together to mutli-faceted view of the organiza ...
-
Manager, GCDO Business
2 weeks ago
Jazz Pharmaceuticals California, United States Full timeBrief Description: · The Manager, GCDO Business & Technology Capabilities demonstrates broad knowledge of the Clinical Development process and the technologies, systems, and applications that support this. The role is responsible for the design, development, production, delivery ...
-
Senior Quantitative Finance Analyst
2 weeks ago
Bank of America California, United StatesJob Description:At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we deliver for our clients, teammates, communities and shareholders every day.One ...
Director/Senior Director Analytical Development - California, United States - Barrington James
Description
Director/Senior Director of Analytical Development
(CA, hybrid or remote with frequent travel)
I've got a great opportunity to join a pioneering biotech company at the forefront of innovative biologics development, specializing in antibodies for infectious and rare diseases. They are committed to revolutionizing treatments and improving patient outcomes with a robust pipeline of potential breakthrough therapies, including a lead candidate in Phase 3 trials, they are poised to make a significant impact in healthcare.
As the Director of Analytical Development with a CMC focus, you will play a pivotal role in advancing their biologics pipeline by leading analytical strategy and development activities related to Chemistry, Manufacturing, and Controls. Reporting to the Vice President of Development, you will oversee a team of scientists and contribute to the successful submission of their first BLA while driving innovation across multiple indications. This position offers a unique opportunity to shape the future of biologics development in a dynamic and collaborative environment.
Key Responsibilities:
Qualifications:
Apply today to learn more or reach out directly with your resume at