- Responsible for manufacturing and supply of clinical trial materials (CTM) for various dosage forms such as sterile injectables, oral solids (tablets, capsules), topicals, Ophthalmics, and nasal products for Phase I-III clinical studies.
- Plan and recommend expansion into contract manufacturing.
- Identify new equipment needs, prepare justification, work with Facilities and Procurement to prepare Capex documents.
- Supervise staff and plan manufacturing schedules.
- Responsible for warehousing, calibration, preventative maintenance (PM) and troubleshooting of all equipment.
- Serve as the Subject Matter Expert (SME) and use knowledge of scientific techniques to troubleshoot processing or product quality issues with a sense of urgency.
- Process and analyze manufacturing results, data and provide appropriate status updates to management.
- Collaborate with product development and Corporate Quality teams to define project tasks, coordinate timelines, and ensure compliance.
- Establish and maintain positive relationships with external partners and internal stakeholders for the benefit of the company and the completion of project deliverables.
- Lead deviation investigations and support on-time closure of deviations and CAPAs for areas of focus.
- Ensure overall audit/inspection readiness and lead regulatory agency inspections.
- Provide feedback and updates to departmental leadership on product/process KPIs.
- Develop and lead Project Management in manufacturing for alignment and prioritization to deliver CTM in accordance with clinical study timelines.
- Manage production and quality control records and the review and approval of Change Controls, CAPAs and other GMP related documents.
- Lead clinical trial material packaging and labeling operation.
- Ensure efficiency, accuracy, timeliness, and cost savings are incorporated into the functional area.
- Minimum BS degree in pharmaceutical, life sciences or related scientific discipline; MBA preferred.
- 10+ years of experience in pharmaceutical manufacturing in cGMP environment.
- Experience in sterile manufacturing is a must.
- Prior experience of working at a CDMO highly desirable
- 5+ years of people management experience
- Strong knowledge of cGMP regulations and working knowledge of US and EU sterile standards
- Strong organizational and time management skills.
- Ability to work well in a team environment, eager, adaptable.
- Excellent oral and written communication skills as well as strong focus and attention to details.
- Ability to perform frequent physical tasks with strength and mobility.
- Demonstrated scientific creativity and technical proficiency.
- Independent and self-starting.
-
CNC Operator Manufacturing Local
3 weeks ago
TheMasonGroup Downingtown, United States**CNC Operator · - Manufacturing · - Local** · - _Looking for a place where you can have a direct path to grow, with a growing, stable organization?_ · - _Giving the opportunity for continuously training & coaching?_ · - _Where you can be part of a company that knows developing a ...
-
Digital Manufacturing Operations Architect
3 weeks ago
AL Solutions Exton, United StatesJob Description · Job DescriptionWe are seeking an experienced program manager to lead the development and execution of our digital manufacturing strategy across operations. This role will spearhead initiatives to transform factory automation through cutting-edge digital solution ...
-
Cybotic System Philadelphia, United States**Position: Manufacturing Technician** · **Location: Philadelphia, PA** · **JOB DESCRIPTION**: · **Job Summary**: · Performs a variety of tasks related to the processing of ingredients and/or pharmaceutical products. Operates general manufacturing equipment, such as autoclaves, a ...
-
Manufacturing Production Operator
3 weeks ago
Fujifilm New Castle, United StatesOverview: · **GENERAL PURPOSE**: · The primary purpose of this position is to manufacture RxD dispersions at the COUS site. · The Production Operator must be responsible to perform all manufacturing activities within all EHS, quality, and corporate guidelines on a right-first-tim ...
-
Director/Sr. Director Manufacturing Operations
2 weeks ago
Frontage Laboratories Exton, United StatesJob Description · Job Description Director/ Senior Director of Manufacturing Operations · Full-time · Exton, PA · Frontage Laboratories: · Frontage Laboratories Inc. (Frontage) is a global contract research and development organization with broad expertise in supporting pre-clini ...
-
Manufacturing Operations Manager
1 week ago
Acara Solutions Collegeville, United States**Senior Operations Manager - Collegeville, PA** · This is a direct hire position. The client is looking for someone coming directly from a large job shop or someone coming from the metals Manufactuing industry. · Metals is a plus. · Core skills/capabilities: Lean Six/Sigma Green ...
-
Manufacturing Operator
3 weeks ago
Alphanumeric Systems King of Prussia, United StatesAlphanumeric is hiring Biopharmaceutical Manufacturing Associates to work in Upper Merion, King of Prussia, PA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements. · Within this team your duties will include; · Being able to wo ...
-
Frontage Laboratories Exton, United StatesFull Time · Management · Exton, PA, US · 30+ days ago · Requisition ID: 1648 · Director/ Senior Director of Manufacturing Operations · Full-time · Exton, PA · Frontage Laboratories · : · Frontage Laboratories Inc. (Frontage) is a global contract research and development orga ...
-
Manufacturing Production Operator
4 days ago
Fujifilm Corporation New Castle, United StatesOverview · GENERAL PURPOSE · Offering $1500 sign on bonus to external candidates. · The primary purpose of this position is to manufacture RxD dispersions at the COUS site. · The Production Operator must be responsible to perform all manufacturing activities within all EHS, qu ...
-
Stellar Innovations Darby, United StatesAbout the Company · With over 35 years of experience, we are one of the leading EMS service providers in the region. As an Electronic Manufacturing Service (EMS), we cover all essential areas of electronic assembly. From order planning, material procurement, warehousing and logis ...
-
Manufacturing Machine Operator
1 week ago
Adecco Wilmington, United StatesJob Description · Job DescriptionAdecco is hiring immediately for Manufacturing Machine Operators with our client site in Wilmington, OH. Weekly pay starting at $16.75 per hour and competitive benefits with options such as medical, dental, vision, and 401(k) . $0.50/hour weekly a ...
-
Bilingual Manufacturing Operations Manager
6 days ago
Addison Group Bellmawr, United StatesAddison Group is currently representing out client, a facilities services company in finding a Bilingual Manufacturing Operations Manager. · About: · Location: 100% in the field – requires daily travel across South New Jersey, Philadelphia, & Surrounding areas · Hours: 1:00 PM ES ...
-
1st Shift Manufacturing Operator
4 days ago
Adare Pharma Solutions Philadelphia, United StatesJob Description · Job DescriptionAre you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufactur ...
-
Manufacturing Group Lead
3 weeks ago
DSM-Firmenich Exton, United States**Manufacturing Group Lead, 1st shift** · **Location: Exton, PA (USA)** · **Onsite (Monday - Friday 6:00am - 2:30pm)** · As a **Manufacturing Group Lead,** you will assure that dsm-firmenich products are of consistent and high quality by producing products in compliance with esta ...
-
Production Operations Assistant
2 weeks ago
The Food Source International, Inc. Exton, United StatesThe Production Operations Assistant is critical to the initiation of the production process and the final release of all manufactured and/or reprocessed materials. This individual will work with the production team to evaluate scheduled production and submit work orders as necess ...
-
Manufacturing Technician,
2 weeks ago
DSM Exton, United States**Manufacturing Technician, (Mechanical Device) 2nd shift** · **Location: Exton, PA (USA)** · **Onsite (Monday - Friday 2:00pm - 10:30pm)** · As a **Manufacturing Technician**, you will maintain an organized workflow and ensure appropriate system transactions are performed in a t ...
-
Manufacturing Technician, 1st Shift- Exton, Pa
2 weeks ago
DSM Exton, United States**Manufacturing Technician, 1st shift** · **Location: Exton, PA (USA)** · **Onsite (Monday - Friday 6:00am - 2:30pm)** · As a **Manufacturing Technician**, you will maintain an organized workflow and ensure appropriate system transactions are performed in a timely and accurate ma ...
-
Quality Analyst
3 weeks ago
Techmatrix inc Exton, United States**Title**: Quality Analyst II · **Position Type**: Contract 1 year with possibility of extension · **Location**: Exton, PA, United States · **Description**: · QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP-compliant analyses of clinical bi ...
-
Machine Operator
3 weeks ago
IDEMIA Exton, United States**Company Overview** · IDEMIA is the global leader in identity and security. Our mission is to create a safe and simple future where identity verification is indisputable, and only you can assert your identity. We are a distributed company leveraging the latest technologies to de ...
-
Human Resources Generalist
2 weeks ago
Innovative Solutions and Support Exton, United States**Overview**: · Innovative Solutions Support located in Exton, PA. Innovative Solutions & Support (IS&S) is a diversified international avionics supplier to civil, military, business, and commercial markets, and operators. IS&S manufactures a broad range of RVSM compliant Air Dat ...
Director/Sr. Director Manufacturing Operations - Exton, United States - Frontage Lab
Description
Director/ Senior Director of Manufacturing OperationsFull-time
Exton, PA
Frontage Laboratories:
Frontage Laboratories Inc. (Frontage) is a global contract research and development organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several global locations and is headquartered in Exton, PA.
Frontage's core competencies include full spectrum of pre-clinical and clinical development including chemistry and manufacturing controls (CMC), safety and toxicology, and bioanalytical services.
CMC:
Our broad portfolio of CMC services cover drug product development comprising formulation development, analytical, scale up, Phase I-III CTM manufacturing, registration batches, and commercial manufacturing.
Our facilities house the latest formulation and analytical equipment for a broad range of dosage forms such as oral solids, sterile, nasal, Ophthalmics and topicals including API/product release, wide spectrum of analytical testing, ICH stability, and commercial testing.
General DescriptionSenior Director/Director, Manufacturing Operations is a key leadership role in the CMC-CDMO Business Unit at Frontage Labs.
This role will report to Executive Vice President, Global CMC and CDMO Services and is responsible for all aspects of manufacturing and packaging operations starting with working with R&D scientists, scale up, and Clinical Trial Material (CTM) manufacturing.
This person will lead a team of 6-10 technicians and operators for technology transfer of sterile and non-sterile dosage forms, scheduling, and management of manufacturing projects.
This role is also responsible for project management, sourcing, warehousing, maintenance of GMP, equipment, and process development.The candidate is expected to have strong technical, communication, and leadership skills to lead internal efforts and interface with Business Development, clients and regulatory authorities.
ResponsibilitiesAll qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
#J-18808-Ljbffr
