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.
Position Summary:
Coordinates activities related to enhancement of existing products/processes and implementation of new product launches. The position requires direct monitoring and engagement of Scale-Up and Post approval changes to support existing products. The position renders Technical expertise and plan activities for new product technology transfer from development/ other sites, Scale-up and manufacturing of ANDA submission batches. The position provides hands on developmental work during the all processes and monitors the manufacturing of all batches and related documentation.
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.)
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:
Industry Experience Required:
Knowledge, Skills and Abilities:
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:
Communication Skills:
Reasoning Ability:
Working Environment:
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:
Salary commensurate with experience.
Excellent benefit and relocation package!
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 #12671 for consideration.
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:
Coordinates activities related to enhancement of existing products/processes and implementation of new product launches. The position requires direct monitoring and engagement of Scale-Up and Post approval changes to support existing products. The position renders Technical expertise and plan activities for new product technology transfer from development/ other sites, Scale-up and manufacturing of ANDA submission batches. The position provides hands on developmental work during the all processes and monitors the manufacturing of all batches and related documentation.
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.)
- Responsible for enhancements for continues improvement of existing products/ processes of solid oral dosage forms.
- Responsible for transfer of technology to manufacturing department during the process validation of submitted/approved products.
- Directly involved in successive phases of developmental and transfer activities including production of research, Scale-Up, Exhibit / Registration for ANDA submission, component changes and process validation batches in a cGMP environment.
- Transfer of technology for new products from the development site/client site to manufacturing site, particularly generic solid dosage forms.
- Responsible for scale-up of approved products.
- Render Technical support for commercial products during routine manufacturing.
- Prepare and review all documentation required for the above activities e. g write strategy documents, related investigations and deviations, standard operating procedures, protocols, reports, etc.
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:
- Educational level required is a Bachelors degree; MSA preferred, in Pharmaceutical Sciences, Industrial Pharmacy or related science discipline.
Industry Experience Required:
- Three (3) to Eight (8) years of pharmaceutical experience.
- Solid oral dosage forms in Product development and/ or Process development in a US/ EU cGMP settings is required.
- Experience with ANDA submission/ approval process, past experience writing regulatory documents and technical reports is required.
Knowledge, Skills and Abilities:
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 Process validation, cleaning validation, regulatory documentation, Product development / formulation and pharmaceutical manufacturing in and USFDA setting is required.
- Demonstrated skills in Scale-up / technology transfer projects.
Communication Skills:
- 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.
- 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:
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.
Salary commensurate with experience.
Excellent benefit and relocation package!
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 #12671 for consideration.
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.