Headquartered in Salisbury, Maryland, Jubilant Cadista Pharmaceuticals Inc. is a noted, top 10 fastest growing generic pharmaceutical company in the United States. Vertically integrated with the parent company (Jubilant Life Sciences) in India, Cadista applies its local market expertise and technical capabilities to all forms of solid dose products to enhance patient outcomes. Cadista employs approximately 300 employees and generates approximately 100MM in annual revenue. The site is uniquely located on the Eastern Shore within 30 minutes east of beautiful Ocean City, Maryland and the same to the Chesapeake Bay to the west. For more information, visit www.cadista.com.
Position Summary:
Reporting to the Director will manage and coordinate activities related to the development of new business opportunities, enhancement of existing products/processes and implementation of new product launches and process changes to support existing products. Explores and evaluates project feasibility with an emphasis on the technology requirements, facility compatibility, compliance issues, and revenue opportunity. Facilitate discussions and negotiations required to develop and obtain closure on internal technology transfer of new products, their scale-up, ANDA batches and development agreements. Demonstrates, understands and implementation of Quality by Design (QbD) in product and process development. Develop and maintain strong relationships with customers, corporate and site personnel and acts as an internal consultant responsible for technical support to manufacturing.
Essential Functions:
(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and qualifications required:
Education:
· Bachelors Degree in Pharmaceutical Sciences or Industrial Pharmacy.
· Master’s degree preferred.
Industry Experience Required:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required:
Knowledge:
Computer Skills:
Reasoning Ability:
Working Environment:
The working environment demands of this job are physically and environmentally centered on characteristics and abilities involved in this work. The work environment considers the risks and discomforts in the physical surroundings and the nature of the work assigned to ensure that all safety regulations and techniques required to perform the job are precautions practical to eliminate all risks.
Physical:
Environmental:
We encourage candidates who meet these requirements to send their resume to tdibiase@jhs.jubl.com and also to apply on our Career Site at http://www.cadista.com/join-our-team/employment-opportunities to Job ID #12652 for consideration.
We offer an excellent benefit package, 401k and relocation assistance!
Salary commensurate with experience
It is the policy of Jubilant Cadista Pharmaceuticals, Inc. (herein “Cadista”) to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity and/or expression, marital status, status as a disabled veteran and/or veteran of the Vietnam Era or any other characteristic protected by federal, state or local law. In addition, Cadista will provide reasonable accommodations for otherwise qualified disabled individuals.
Position Summary:
Reporting to the Director will manage and coordinate activities related to the development of new business opportunities, enhancement of existing products/processes and implementation of new product launches and process changes to support existing products. Explores and evaluates project feasibility with an emphasis on the technology requirements, facility compatibility, compliance issues, and revenue opportunity. Facilitate discussions and negotiations required to develop and obtain closure on internal technology transfer of new products, their scale-up, ANDA batches and development agreements. Demonstrates, understands and implementation of Quality by Design (QbD) in product and process development. Develop and maintain strong relationships with customers, corporate and site personnel and acts as an internal consultant responsible for technical support to manufacturing.
Essential Functions:
(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)
- Performs all supervisory duties for exempt level scientists and hourly technicians. Assigns daily work, hiring, performance management, training and other managerial duties.
- Develops relationships and communicates to explain proposals, present research findings, establish specifications or discuss project status of Product Development of solid oral dosage forms.
- Develops project planning, timelines and logistical programs to match new product launches, contract manufacturing projects and process changes that are required for life cycle management of existing products.
- Transfer of technology for new products from the development or other sites to manufacturing site, particularly generic solid dosage forms.
- Responsible for transfer of technology to manufacturing during the process validation of submitted/approved products.
- Plan and manage successive phases of developmental and transfer activities including production of research, Scale-Up, Exhibit/ Registration for ANDA submission, component changes and process validation batches.
- Prepare and deliver project proposals and technical support to manufacturing, review of SOP, Protocols, reports etc.
- Responsible for all documentation required for the above activities e. g write and/or approves Standard Operating Procedures, Protocols, Reports, Strategy documents etc.
- Writes and manages department SOP’s, training etc. to ensure regulatory compliance and operations enhancement. Responsible for site transfer and technology transfer of new product.
- Implementation of QbDs for new and existing products.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and qualifications required:
Education:
· Bachelors Degree in Pharmaceutical Sciences or Industrial Pharmacy.
· Master’s degree preferred.
Industry Experience Required:
- Five (5) plus years of pharmaceutical experience with solid oral dosage forms is required.
- Three (3) to five (5) or more years of progressive supervisory experiences required.
- Requires experience in generic solid dose products and/ or process development and scale up.
- Experience in process validations is an added advantage.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required:
Knowledge:
- Demonstrated knowledge and understanding of solid oral dosage formulation process, manufacturing processes and equipment.
- Demonstrated knowledge and working understanding of basic concepts of Good Manufacturing Practices (GMP) is required.
- Demonstrated experience with Regulatory documentation, Product development / formulation and pharmaceutical manufacturing in and USFDA setting is required.
- Demonstrated skills in Scale-up / technology transfer projects.
- Advance level oral and written communication skills with the ability to speak and write with clarity and structure.
- Ability to interpret and prepare technical reports with clarity and ease of presentation.
Computer Skills:
- Proficient skills level with using Microsoft applications, including Word, Excel, SAP.
- Other software knowledge and experience preferred but not required.
Reasoning Ability:
- Good subject knowledge and problem solving skills required.
Working Environment:
The working environment demands of this job are physically and environmentally centered on characteristics and abilities involved in this work. The work environment considers the risks and discomforts in the physical surroundings and the nature of the work assigned to ensure that all safety regulations and techniques required to perform the job are precautions practical to eliminate all risks.
Physical:
- No special physical demands required to perform this work.
- Work does require work within the manufacturing environment which may require extended periods of standing, reaching and walking.
- Must exercise extreme safety and precaution at all times in all designated cGMP areas in the facility.
Environmental:
- Work is regularly performed inside in an office and manufacturing environment. Requires use of personal protective equipment in designated areas.
- The work area involves everyday risks or discomforts requiring normal safety precautions typical of such places as offices, meeting and training rooms, etc. Use of safe work practices with office equipment required.
- Work area is adequately lighted, heated and ventilated.
We encourage candidates who meet these requirements to send their resume to tdibiase@jhs.jubl.com and also to apply on our Career Site at http://www.cadista.com/join-our-team/employment-opportunities to Job ID #12652 for consideration.
We offer an excellent benefit package, 401k and relocation assistance!
Salary commensurate with experience
It is the policy of Jubilant Cadista Pharmaceuticals, Inc. (herein “Cadista”) to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity and/or expression, marital status, status as a disabled veteran and/or veteran of the Vietnam Era or any other characteristic protected by federal, state or local law. In addition, Cadista will provide reasonable accommodations for otherwise qualified disabled individuals.