Associate Manager/Manager Drug Substance
3 weeks ago
Overview
Celldex is a high growth clinical-stage biotechnology company focused on the development of immunotherapies for the treatment of inflammatory diseases and cancer. Celldex has validated pipeline programs, an experienced management team who pioneered early antibody technologies, and support from leading healthcare investors. At Celldex, you'll work with some of the industry's most talented scientists and business professionals in a meaningful, inclusive, and exciting work environment to help build a commercial team from the ground up. The Associate Manager/ Manager Drug Substance works cross-functionally with internal and external teams to support drug substance (DS) GMP external manufacturing, process characterization and validation for commercialization of pipeline drug candidates while adhering to Good Manufacturing Practices, company policies and procedures.
Responsibilities
* Support drug substance (DS) GMP external manufacturing, process characterization and validation for commercialization of pipeline drug candidates.
* Review CDMO batch record, protocol, and reports. Lead/ support troubleshooting, process risk analysis and manufacturing investigations.
* Serve as a person-in-plant (PIP) to assist in management of CDMO activities.
* Support authoring and/ or review of CMC sections for regulatory submissions.
* Collaborate closely with internal and external cross-functional teams like analytical, formulation, quality assurance and regulatory to support batch release, manufacturing investigations, testing and stability programs.
Qualifications
* Interpersonal skills to effectively manage internal and external communications.
* Able to travel 10-15 % of time.
* Proficient in the use MS Outlook, Word, Excel, Project, PowerPoint, Visio.
Education/Experience:
* Master's degree with 6+ years of experience in Chemical engineering or Biochemical engineering or Biochemistry or Biological Sciences.
* 2+ years of experience in managing biologics CDMOs.
* 1+ years of experience in managing late-phase biologics programs.
* Able to travel 10-15 % of time.
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
-
Hampton, United States Family Restoration Services Full timeJob DescriptionJob DescriptionFamily Restoration Services is seeking a Certified Substance Abuse Counselor to apply and interpret therapeutic standards to a variety of clients with substance abuse and/or emotional impairments. Counselor will use cognitive-behavioral skill building techniques and administer Substance Abuse Subtle Screening Inventory (SASSI)...
-
Branch Manager
7 days ago
Hampton, United States BayPort Credit Union Full timeThe primary purpose of the Branch Manager position is to provide excellent quality service to current and potential Credit Union members. The Branch Manager is responsible for working with staff to meet or exceed sales and service goals, providing quality service to the members, coaching and developing assigned staff, and overseeing daily operations of the...
-
Manager, Homeless Services
1 month ago
Hampton, United States Hampton-Newport News Community Services Board Full timeJob DescriptionJob DescriptionHomeless Services ManagerWork Schedule: Monday-Friday 8:30 am-5 pmSalary: $58,269The Safe Harbors Program is intended to reduce homelessness by providing housing first. It is also designed to maximize consumers' opportunities and independence by providing quality support, training, and individualized services to individuals...
-
Assistant Property Manager
6 days ago
Hampton, United States BECO Full timeRapidly growing Property Management company is seeking an experienced Assistant Property Manager in Hampton, VA. Our Property Management teams are the cornerstone of our business. They are responsible for keeping our communities in the top-notch condition our residents have come to expect and deliver a notably higher level of service while maximizing the...
-
Hampton, United States BENEVOLENT FAMILY SERVICES LLC Full timeJob DescriptionJob DescriptionWe are a steadily growing company that believes our team is our top priority. Join our team today!Benevolent Family Services was founded in January 2014. All staff of Benevolent Family Services is devoted to professional and quality services in a timely fashion. At Benevolent Family Services our mission is to demonstrate...
-
Hampton, United States BENEVOLENT FAMILY SERVICES LLC Full timeWe are a steadily growing company that believes our team is our top priority. Join our team today! Benevolent Family Services was founded in January 2014. All staff of Benevolent Family Services is devoted to professional and quality services in a timely fashion. At Benevolent Family Services our mission is to demonstrate goodwill toward those with...
-
Adult Mental Health Case Manager
3 weeks ago
Hampton, United States Hampton-Newport News Community Services Board Full timeJob DescriptionJob DescriptionCase Manager - Adult Mental HealthSchedule: Monday-Friday 8:30 am - 5:00 pmSalary: $47,250The Hampton - Newport News Community Services Board is a dedicated provider of comprehensive mental health services with a mission to support individuals with Serious Mental Illness or Serious Mental Illness and Co-occurring Substance Use...
-
Assistant Property Manager
5 days ago
Hampton, United States BECO Full timeJob DescriptionJob DescriptionRapidly growing Property Management company is seeking an experienced Assistant Property Manager in Hampton, VA. Our Property Management teams are the cornerstone of our business. They are responsible for keeping our communities in the top-notch condition our residents have come to expect and deliver a notably higher level of...
-
Property Manager
3 days ago
Hampton, United States Harrison & Lear, Inc. Full timeJob DescriptionJob DescriptionProperty ManagerOne of our Peninsula multi-family communities is seeking a Property Manager. Property Management is a fast-growing industry that promotes a strong team approach. When you work with our company, you become part of the family!We provide our employees with the training and support they need to reach their goals...
-
Associate Manager
5 days ago
East Hampton, United States Mosaic Full time**Hourly Rate: $19.46 Per Hour** If making a positive impact in the lives of others is always on your to-do list — you’ll LOVE working with a team that puts people first. We’re looking for an **Associate Direct Support Manager** to join our team! The Associate Direct Support Manager plays a key role in managing the operations of the Residential and...
-
Manager, Homeless Services
1 month ago
Hampton, United States Hampton-Newport News Community Services Board Full time**Homeless Services Manager** **Work Schedule: Monday-Friday 8:30 am-5 pm** **Salary: $58,269** The Safe Harbors Program is intended to reduce homelessness by providing housing first. It is also designed to maximize consumers' opportunities and independence by providing quality support, training, and individualized services to individuals who are homeless...
-
Addiction (ARTS) Case Manager
3 weeks ago
Hampton, United States Elevance Health Full timeAddiction (ARTS) Case Manager MUST LIVE WITHIN THE TIDEWATER REGION (Accomack County, Chesapeake County, Franklin City, Isle of Wight County, Hampton City, Norfolk City, Newport News City, North Hampton County, Portsmouth City, Suffolk City, Virginia Beach City, VA) A proud member of the Elevance Health family of companies, Carelon Behavioral Health,...
-
Psychiatric Mental Health Nurse Practitioner
7 days ago
Hampton, United States Hampton-Newport News Community Services Board Full timeJob DescriptionJob DescriptionWork Schedule: Monday - Friday 8a to 4:30pPartners in Recovery is a leading provider of high-quality, comprehensive outpatient counseling, medication management, and medication-assisted treatment services. We specialize in offering support to adults who are navigating the challenges of substance use and co-occurring mental...
-
Case Manager
12 hours ago
Hampton, United States Hampton-Newport News Community Services Board Full timeJob DescriptionJob DescriptionJoin our dynamic team at Hampton-Newport News Community Services Board as a Full Time Case Manager with Hampton Healthy Families program! This exciting opportunity allows you to make a real impact in the lives of families and youth in our community. As a Case Manager, you will have the chance to utilize your empathetic nature...
-
Adult Mental Health Case Manager
6 hours ago
Hampton, United States Hampton-Newport News Community Services Board Full timeJob DescriptionJob DescriptionAdult Mental Health Case ManagerSchedule: Monday-Friday 8:30 am - 5:00 pmSalary: $47,250Are you passionate about making a positive impact on the lives of adults living with a mental health illness? Join our team at Hampton-Newport News Community Services Board as a Full-Time Adult Mental Health Case Manager! In this role, you...
-
Intensive Care Coordination Case Manager
7 days ago
Hampton, United States Hampton-Newport News Community Services Board Full timeJob DescriptionJob DescriptionJoin the Hampton-Newport News Community Services Board and make a difference in the lives of children and adolescents in need. As a Full-Time Intensive Care Coordination Case Manager, you will have the opportunity to work in Hampton and Newport News, VA, providing crucial support and guidance to our community's youth. This...
-
Case Manager
1 week ago
Hampton, United States Hampton-Newport News Community Services Board Full timeJob DescriptionJob DescriptionJoin the Hampton-Newport News Community Services Board as a Full Time Case Manager specializing in Child and Adolescent Mental Health! This role offers a unique opportunity to make a tangible difference in the lives of young individuals facing mental health challenges. You'll have the chance to provide crucial support,...
-
General Manager
7 days ago
Hampton, United States Element Hampton Peninsula Town Center Full timeJob DescriptionJob DescriptionLTD Hospitality Group is seeking highly motivated, strategic leaders with expertise in effective and efficient hotel operations. Our ideal candidates should exude a passion for the hospitality industry that will attract and inspire associates to cultivate an exceptional guest experience. If you are looking for an exciting career...
-
General Manager
5 days ago
Hampton, United States Applebee's - Potomac Family Dining Group Full timeThis position is under the direct supervision of the Area Director of Operation or Executive General Manager and provides restaurant leadership in accordance with established company standards. ESSENTIAL DUTIES AND TASKS: Manages Restaurant Environme General Manager, Associate Manager, Manager, Assistant Manager, Guest Experience, Team Lead, Management
-
Head, Pharmacovigilance
3 weeks ago
Hampton, United States Celldex Therapeutics Full timeOverview The Head of Pharmacovigilance and Risk Management provides strategic leadership and tactical oversight of the clinical safety department. Serves as subject matter expert for all medical and safety needs. Oversee submission for safety reports, interacts with regulatory authorities, monitors safety across all programs. Reports to the...