Process Development Scientist-DP PD
Puerto Rico, us-territories - USA
Job Summary
DESCRIPTION
To conceive design implement and execute specific scientific experiments which contribute to the successful completion of goals and/or projects under general guidance of and designs executes or evaluates and interprets experimental input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise including literature and technology development and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports summary documents complex regulatory documents invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team
EDUCATION
Doctorate degree or Master degree and 2 years of Scientific experience or Bachelor degree and 4 years of Scientific experience.
Academic background in Life Sciences or Engineering (Biochemistry Chemical Engineering
SKILLS
Ultimate Solutions Corp is an Equal Opportunity Employer
To conceive design implement and execute specific scientific experiments which contribute to the successful completion of goals and/or projects under general guidance of and designs executes or evaluates and interprets experimental input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise including literature and technology development and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports summary documents complex regulatory documents invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team
EDUCATION
Doctorate degree or Master degree and 2 years of Scientific experience or Bachelor degree and 4 years of Scientific experience.
Academic background in Life Sciences or Engineering (Biochemistry Chemical Engineering
SKILLS
| Relevant experience in a commercial biopharmaceutical manufacturing environment preferably supporting formulation and aseptic filling operations. Understanding of protein science formulation and filling processes. Experience with process monitoring data trending and statistical analysis tools (e.g. JMP) Experience supporting deviations investigations root cause analysis and product impact assessments. Ability to provide manufacturing floor support in a fast-paced 24/7 operation. Bilingual proficiency in Spanish and English (written and verbal). Strong technical writing skills with experience preparing documentation for regulatory audits. Excellent communication presentation problem-solving project management skills and cross-functional collaboration skills. |
Ultimate Solutions Corp is an Equal Opportunity Employer
Required Experience:
IC
About Company
Ultimate Solutions is the leading partner in packaging industrial automation, serialization and compliance for the Life Science’s Industry.