- PhD/MS/BS in Biochemistry, Chemical Engineering, or related field with a minimum of 10 years of experience in biopharmaceutical industry.
- Hands-on experience working in a cleanroom environment and in drug product manufacturing of biologics.
- Experience and knowledge in the entire drug product manufacturing process, from drug substance thawing and compounding, sterile filtration, filling, stoppering, lyophilization, capping, to visual inspection and labeling.
- Familiar with filtration systems, filling lines, filling isolators, and environmental monitoring.
- Experience in CDMO management and working closely with the Quality Assurance and Clinical Supply Chain Management functions.
- Experience in risk management, deviation and root-cause investigations and CAPAs.
- Experience in writing CMC sections of IND and BLA.
- Experience in formulation development, lyophilization cycle development, drug product process characterization and validation, equipment validation, and cleaning validation are highly desired.
- Must be proactive, detail-oriented, collaborative, and able to work effectively in a fast-paced environment with minimal supervision.
- Excellent communication, organization, and collaborative skills are essential.
-
Senior Director, Process Development
3 days ago
VALID8 Financial Wilmington, United StatesCabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA platform includes two strategies to treat and potentially cure many of the ...
-
Incyte Wilmington, United StatesOverview: · Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and develo ...
-
Lead Developer
4 days ago
MRA Group Wilmington, United States**Position Summary**: · The Lead Developer position for MRA Group and its related entities ("Company") is responsible for the planning, development, financial analysis and accountability, and managing of the development of Chestnut Run Innovation and Science Park (CRISP) for Comp ...
-
Business Analyst
10 hours ago
One Mnet Health Willington, United StatesJob Summary: · **Duties**: · - Perform tasks including daily SCRUM meetings, backlog grooming, and sprint planning. · - Collaborate with business stakeholders to gather and document requirements for technology projects and initiatives. Collaborates with stakeholders to define sol ...
-
Nurse Manager Ambulatory-foulk Road
1 day ago
Nemours Wilmington, United StatesNemours is seeking a Nurse Manager-Ambulatory · - Foulk Road, Wilmington, DE location. · **Primary Functions**: · This position is responsible for: · Facilitates, coordinates and directs patient care services and provides leadership for designated area(s) of responsibility. Respo ...
-
Business Analytics
2 days ago
M&T Bank Wilmington, United StatesOverview: · This position will be responsible for providing support to their unit (dept) working across several simultaneous projects/programs by creating new reports and dashboards, expanding on existing metrics, as well as continuous review for data improvement. · Location: Thi ...
-
Director Supply Chain and Demand Planning
10 hours ago
LEDVANCE Wilmington, United States**SUMMARY**: Director of Supply Chain and Demand Planning oversees all aspects of product demand, forecasting, and supply chain activities associated with LEDVANCE products in the United States and Canada; Manage the supply chain life cycle from the development and implementation ...
-
Business Process Manager I
3 days ago
TD Bank Wilmington, United States**Work Location**: · Remote Wilmington (DE) No City Tax · **Hours**: · 40 · **Pay Details**: · $68,640 - $112,320 USD · **Line of Business**: · Enterprise Enabling Functions · TD Bank's Credit Cards and Unsecured Lending organization offers consumer credit in three areas: TD-bran ...
-
Program Development Director
3 days ago
Democratic National Committee Wilmington, United States**Overview**: · The DNC is seeking a Program Development Director. The director will lead a team of program development managers to develop campaign programs for battleground states, aligning with overarching campaign strategies. We are looking for folks with a variety of backgro ...
-
TD Bank Wilmington, United States**Work Location**: · Remote Wilmington (DE) No City Tax · **Hours**: · 40 · **Pay Details**: · **Line of Business**: · Sales & Customer Distribution Support · US Fraud Capacity Planning and Workforce Management, will manage full scope of capacity planning for US Fraud Operations ...
-
Accounts Payable Supervisor
4 days ago
Symbotic Wilmington, United States**Who we are** · With its A.I.powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system - reinventing warehouse automation for increased ef ...
-
Research Scientist
5 days ago
Universal Display Corporation Wilmington, United States**Adesis Inc. - a subsidiary of Universal Display Corporation (Nasdaq: OLED),** a global leader in organic light emitting diodes - is a premier contract development and manufacturing organization (CDMO) accelerating our clients' success in the biotech, pharmaceutical and specialt ...
-
Employment Services Specialist Iii
4 days ago
State of Delaware Wilmington, United StatesThe Employment Services Specialist III conducts comprehensive assessments, develops individual employment plans, provides case management/training services working with job seekers to obtain occupational skills training, OJT, skills upgrading, job readiness training. Identifies e ...
-
Global Strategy
4 days ago
Dupont Wilmington, United StatesAt DuPont, we are working on things that matter; whether it's providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric vehicles, or protecting workers around the world. · ...
-
Fiscal Management Analyst
2 days ago
State of Delaware New Castle, United States**Introduction**: · **Make a Difference with DHSS** · Our mission at the Department of Health and Social Services (DHSS) is to improve the quality of life of Delaware citizens by promoting health and well-being, fostering self-sufficiency, and protecting vulnerable populations. W ...
-
Implementation Manager
4 days ago
Securitas Electronic Security Inc. Wilmington, United States**Position Summary** · The Nurse Call Implementation Manager will manage a Technician Team serves as the Regional Lead maintaining oversight of projects is the primary point of contact for the customer or a partner and is responsible for ensuring successful completion of project ...
-
Library Assistant I
2 days ago
Wilmington University New Castle, United States**EMPLOYMENT OPPORTUNITY** · **DATE**: May 10, 2024 · **FROM**: Human Resources · **POSITION**: Library Assistant I (PT) · **Effective immediately**: (PT) Library Assistant I - Library, Wilmington University, New Castle. · **Requirements**:Bachelor's degree or equivalent is requi ...
-
Accounts Receivable Specialist
3 days ago
Watson-Marlow Fluid Technology Solutions Wilmington, United States**Location: WMFTS Recruiting Locations** · **Benefits: Enhanced Carer/Paternity Leave, Additional Holiday, EAP and more** · We're currently seeking a Accounts Receivable Specialist to join us. You'll join a dynamic team of engineers, sales people, marketers, administrators, desig ...
-
Registered Dietitian
4 days ago
Fresenius Medical Care Wilmington, United States Full timePOSITION FEATURES:State Licensure Required · Full Time RD: 36 Hours Per Week · Full Benefits Included · Associate Level or Registered Dietitian. · Description · Provide your personal attention and kindness, professional insight, and a generosity of spirit. Offer expertise and en ...
-
Mainframe Developer
5 days ago
Envision Technology Solutions Wilmington, United StatesMandatory Skills : JCOBOL, JCL, DB2, CICS, IMS DB/DC. · Process Skills: · - Thorough understanding of the software development lifecycle · - **Outstanding written/verbal communication skills with experience distilling and presenting complex quantitative analysis** · Pay: $110, $1 ...
Associate Director, Drug Product Process Development - Wilmington, United States - Incyte
Description
OverviewIncyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Job Summary (Primary function):
The Associate Director, Drug Product Process Development, reporting to DP Technologies (DPT) in Global Biopharmaceutical Development (GBD), is a critical role in our development team and will help lead the successful development and commercialization of biologics product candidates. Individuals who are self-motivated, enthusiastic team players with a passion for playing a key role in the development of life-saving medicines are encouraged to apply. Expertise and experience in large molecule/biologics DP process development and validation and CDMO management are required. The incumbent will work with internal and external team members to meet Company timelines and objectives. Responsibilities include but not limit to drug product process development, process validation as well as preparation of CMC sections for regulatory submissions and updates.
Incyte is a fast-paced biopharmaceutical company of passionate employees, and there is substantial opportunity for the ideal candidate to grow and develop with the organization. Individuals will have the opportunity to work on projects and take on responsibilities that may fall outside their immediate scope of work.
The job is based in Wilmington Delaware, US.
Essential Functions of the Job (Key responsibilities):
Design and develop phase appropriate process/manufacturing to support preclinical and clinical studies.
Lead in RFP writing, technical transfer, process and method development, optimization, qualification, validation, and activities related to all manufacturing operations.
Evaluate third-party manufacturers by working with Quality Assurance and Regulatory Affairs, negotiate effective supply/technical agreements.
Work closely with contract manufacturers (CMOs), Supply Chain leads, Quality and operations partners to ensure supply continuity with optimal cost and quality.
Manage Interactive Response Technology (IRT) systems from specification, user acceptance testing and release to support randomization and management of CTM.
Manage investigation, reporting and communication of outcomes from temperature excursions, product complaints, etc.
Design and oversee execution of drug product activities in preparation for registration and validation, and commercial activities.
Manage and execute Primary/Registration batch manufacturing aligned with regulatory filings.
Participate in cross functional project teams for product development as CMC functional area representative.
Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator's Brochure and Pharmacy Manual.
Ensures that key project milestones and schedules are met.
Manage consultants, vendors, and CDMOs to meet agreed upon program timelines/budgets.
Travel to various CDMO sites (20%).
Other projects as assigned.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy
Learn more at:
The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).
Please contact if you have any questions or concerns or would like to exercise your rights.
