Current jobs related to Senior Manager/Associate Director of Drug Substance Manufacturing Process Characterization and Proce - Bala Cynwyd PA - Larimar Therapeutics
-
Director of Residence Management
3 days ago
Bala Cynwyd, United States LCB Senior Living, LLC Full timeJob SummaryWe are seeking an experienced Executive Director to lead the day-to-day operations of our senior living community. The successful candidate will be responsible for ensuring the highest level of quality care and service is provided to our residents, while also driving business growth and excellence.Key ResponsibilitiesLeadership and Management:...
-
Executive Director
3 days ago
Bala Cynwyd, United States LCB Senior Living, LLC Full timeJob SummaryWe are seeking an experienced Executive Director to lead the day-to-day operations of our senior living community. The successful candidate will be responsible for ensuring the highest level of quality care and service is provided to our residents, while also driving business growth and excellence.Key ResponsibilitiesLeadership and Management:...
-
Executive Director
1 month ago
Bala-Cynwyd, United States Arrow Consulting Full timeJob DescriptionJob DescriptionRecovery Home is seeking an Executive Director for an outpatient substance use disorder treatment facility in Bala Cynwyd, PA. The program provides PHP, IOP, and OP services to adults (18+).The Executive Director is responsible for the leadership, overall operations, management, and success of the facility. Responsible for...
-
Senior Nursing Leader
2 days ago
Bala-Cynwyd, Pennsylvania, United States LCB Senior Living Full timeJob SummaryLBC Senior Living is seeking a highly skilled and compassionate Nursing Supervisor to join our team at The Residence at Bala Cynwyd. As a key member of our Resident Care Department, you will be responsible for overseeing the daily operations of our skilled care unit, ensuring the highest level of quality care and service to our residents.Key...
-
Senior Tax Analyst
2 weeks ago
Bala Cynwyd, United States Jobot Full timeExciting Career Opportunity for a Skilled Tax SeniorJobot, a leading public accounting firm, is on the lookout for a knowledgeable Tax Senior to enhance our vibrant team. This role provides the flexibility to work remotely, in-office, or a combination of both.What We Provide:Attractive base salaryComprehensive benefits packageChance to collaborate with a...
-
Nursing Supervisor
2 days ago
Bala-Cynwyd, Pennsylvania, United States LCB Senior Living Full timeJob SummaryLBC Senior Living is seeking a highly skilled and compassionate Nursing Supervisor to join our team at The Residence at Bala Cynwyd. As a key member of our healthcare team, you will be responsible for providing exceptional care and support to our residents, while also overseeing the daily operations of our nursing department.Key...
-
Nursing Supervisor
3 months ago
Bala Cynwyd, United States LCB Senior Living Full timeJob Details Description **FULL TIME DAYS**PREMIUM SALARY**SCHEDULED MON-FRI** LCB Senior Living is hiring a Nursing Supervisor at The Residence at Bala Cynwyd! **Must have Nursing License** Benefits starting day 1! Health Vision Dental Life Insurance 401k Paid time off (after grace period) Opportunity for Growth ...
-
Merrill Market Client Relationship Manager
3 weeks ago
Bala-Cynwyd, Pennsylvania, United States Bank of America Full timeJob 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 of the keys to driving Responsible Growth is being a great place to work for our...
-
Executive Director
1 month ago
Bala Cynwyd, United States LeaderStat Full time*Senior Living Executive Director - Bala Cynwyd, PA*LeaderStat is partnering with a leading senior housing provider with more than 25 years of excellence who is seeking a permanent Executive Director for a newer, high-end senior living community in Bala Cynwyd, PA.This community has a solid leadership team and an AMAZING care staff! This is a strategically...
-
Executive Director
2 months ago
Bala-Cynwyd, United States LeaderStat Full time*Senior Living Executive Director - Bala Cynwyd, PA*LeaderStat is partnering with a leading senior housing provider with more than 25 years of excellence who is seeking a permanent Executive Director for a newer, high-end senior living community in Bala Cynwyd, PA.This community has a solid leadership team and an AMAZING care staff! This is a strategically...
-
Executive Director
6 days ago
bala-cynwyd, United States LeaderStat Full time*Senior Living Executive Director - Bala Cynwyd, PA*LeaderStat is partnering with a leading senior housing provider with more than 25 years of excellence who is seeking a permanent Executive Director for a newer, high-end senior living community in Bala Cynwyd, PA.This community has a solid leadership team and an AMAZING care staff! This is a strategically...
-
Wealth Management Associate
3 months ago
Bala-Cynwyd, United States Equitable Advisors Full timeEquitable Advisors is a leading firm in the financial services and insurance industry with a mission to help people build fulfilling futures grounded in our stability, innovative solutions and commitments to our clients. Equitable Advisors is currently seeking to onboard a new Retirement Benefits Group (RBG) Financial Professional.What it takes to be an...
-
Senior User Acceptance Testing Specialist
2 weeks ago
Bala Cynwyd, United States Tokio Marine North America, Inc. Full timeCompany Overview: Tokio Marine North America Services (TMNAS) is dedicated to delivering exceptional support services to the Tokio Marine Group companies throughout the United States. Our commitment to customer service is paramount, and we strive to add value in every interaction, empowering our business partners to reach their objectives. Our skilled team...
-
Senior Financial Analyst
2 months ago
Bala Cynwyd, United States Pep Boys Full timeOverview Pep Boys is driven by its customer promise, “We go further to help you go farther.” Founded 100 years ago by military veterans, generations of drivers have counted on Pep Boys ASE-certified Pros to service their vehicles. With a national network of over 900 locations in 35 states and Puerto Rico, and 20+ distribution centers, Pep Boys employs...
-
Tax Senior Associate
5 days ago
Bala Cynwyd, United States Jobot Full timeJoin Our Team as a Tax SeniorWe are a thriving public accounting firm seeking a skilled Tax Senior to enhance our talented team. This role provides the flexibility to work remotely, in-office, or a combination of both, catering to your work preferences.What We Provide:Attractive base salaryComprehensive benefits packageDiverse client portfolioOpportunities...
-
Senior Audit Associate
2 weeks ago
Bala Cynwyd, United States Jobot Full timeJoin Jobot as an Audit Senior in a Thriving Public Accounting FirmThis remarkable role offers a balanced work-life environment with a 35-hour workweek during peak periods. Become part of a vibrant team in a Remote/Hybrid work arrangement.About Jobot:Jobot is a reputable public accounting firm seeking a talented Audit Senior to enhance our team.Why Work with...
-
Director of Health
4 months ago
Bala Cynwyd, United States Elegance Living Full timeResponsibilities: Oversee resident health and safety, clinical operations, and regulatory compliance. Manage resident health assessments, care planning, and condition changes. Supervise, hire, coach, train, and evaluate Assisted Living and Memory Care staff. Coordinate Assisted Living and Memory Care team member schedules and duties. Lead risk...
-
Deputy Director of Public Policy and Partnerships
3 months ago
Bala-Cynwyd, United States Alliance for Decision Education Full timeJob DescriptionJob DescriptionSalary: WHO WE AREThe Alliance for Decision Education (“the Alliance”) is a national nonprofit and field builder with the mission of improving lives by empowering students with essential skills and dispositions for making better decisions. Founded in 2014 and backed by experts in decision sciences, business, and...
-
Development Associate
7 days ago
Bala-Cynwyd, United States Velocity Venture Partners Full timeJob DescriptionJob Description Role Details:Assists in the day-to-day management of project-specific land development from planning and entitlements through project completion.Ensures that the work is within compliance of City and/or County requirements.Works with SVP to administer multi-vendor consulting teams in preparation and processing of land use...
-
Senior Executive Assistant
7 days ago
Bala-Cynwyd, United States Alliance for Decision Education Full timeJob DescriptionJob DescriptionSalary: WHO WE AREThe Alliance for Decision Education (the Alliance) is a national nonprofit and field builder withthe mission of improving lives by empowering students with essential skills and dispositionsfor making better decisions. Founded in 2014 and backed by experts in decision sciences,business, and education—including...
Senior Manager/Associate Director of Drug Substance Manufacturing Process Characterization and Proce
1 month ago
Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.
The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.
Senior Manager/Associate Director of Drug Substance Manufacturing Process Characterization and Process Validation within the Larimar Technical Operations Departments
Reports to: Director, CMC Technical Operations
This position will be part of the Drug Substance Manufacturing Team within the Larimar Technical Operations Group. The person who fills this role should have drug substance (DS) process development (PD), manufacturing (MFG), and process validation (PC/PPQ) that are executed at Larimar's external partners. Oversight of Process Characterization and Process Performance Qualification at CSPs for late stage clinical asset.
Lead risk assessments, protocol generation/review, scaled down model qualification, process control strategy, PPQ Master plan generation/review, end of production banking, etc. Authoring and managing continued process verification (CPV), annual updates to INDs, BLAs, annual product reviews (APRs)
Data entry, data analysis and data trending.
Communicate between CSP and project managers, quality and regulatory stakeholders, and senior leaders.
Maintains a good understanding of Regulatory and Quality aspects appropriate to all aspects of work.
Performing presentations at team, department and project meetings while collaborating with other groups within Larimar.
Direct intermediate between R&D and contract service providers (CSPs) to take new assets from R&D into first in human clinical trials via right first time, DOE, and QbD development.
Cross functional contributor with Upstream and Downstream drug substance leads to develop scalable processes based on manufacturing capabilities.
Opportunity to develop platform process for future assets in conjunction with Upstream and Downstream drug substance leads.
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 substance manufacturing of biologics.
Experience and knowledge in the entire drug substance manufacturing process with upstream and downstream knowledge of E. coli systems preferred. GxP experience in a Technical Operations group (Process Development, Manufacturing or Manufacturing Science and Technology, MSAT) in PD or MFG under ICH/FDA guidelines is required.
Experience working under global regulatory agencies such as the EMA and HC is highly desirable.
Experience in risk management, deviation, 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.
Experience with Microsoft Suite is required, experience with Microsoft teams is desirable.
Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.
We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.
Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. employees are made in a non-discriminatory manner—without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.
