Frontida is actively recruiting innovative and caring professionals. Here, you can help develop and build a culture of caring, accountability and continuous improvement (both individually and corporately). Frontida careers extend from pharmaceutical formulation scientists to quality assurance specialists, information technology to regulatory compliance professionals, and manufacturing to mechanical specialists. Join a powerful, results-oriented team.

Job Summary

Job Summary

We are seeking associate analytical scientist to join our Analytical R&D team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation development by performing analytical testing and assisting in analytical method development and validation activities for both ANDA and NDA projects

Responsibilities

Responsibilities

  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples to support new product formulation development for both ANDA and NDA projects
  • Participate in analytical method development
  • Conduct and document method verification, method transfer, and method validation as per approved method validation protocols, Company SOPs and ICH Guidance
  • Conduct and document in-process and finished product testing for product release and stability as per the approved test methods
  • Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, Safety and scientific training’s to remain current with cGMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

Qualifications:

  • MS in Chemistry or related major with 0-2 years of experience or a BS degree with 0-3 years’ experience is preferred. Experience with generic drug analysis is desirable.
  • Good understanding of chemical and physical analysis principles, knowledge and experience in chromatography analysis, UV, IR, and dissolution is preferred.
  • Fundamental understanding of GMP, ICH and FDA compliance is preferred.
  • Good written and oral communication skills and interpersonal skills.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Job Summary

We are seeking analytical Scientists to join our Analytical R&D team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation development by performing method development, validation, writing protocols and reports, conducting chemical and physical testing activities for both ANDA and NDA projects.

 

 

Responsibilities

Responsibilities

  • Develop and evaluate analytical test methods for raw materials and in-process and finished products
  • Write protocols and reports.
  • Conduct and document chemical and physical testing of finished products, raw materials, API, in-process products, stability samples to support new product formulation development for both ANDA and NDA projects
  • Conduct and document method verification and method validation as per approved method validation protocols, Company SOPs, FDA Guidance, and ICH Guidelines
  • Conduct and document in-process and finished product testing for product release and stability as per the approved test methods
  • Effectively communicate with cross functional teams like Formulation Development, Quality Control, Quality Assurance, Compliance and Regulatory Affairs
  • Attend SOP, Safety and scientific training’s to remain current with cGMP regulations, and safety standards
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

Qualifications:

  • Ph. D. in Chemistry or related majors with 0-3 years of experience, or a MS degree with 2+ years of experience, or a BS with 5+ years of experience is preferred.
  • Good understanding of chemical and physical analysis principles, experience in method development is preferred.
  • Fundamental understanding of GMP, ICH and FDA compliance is preferred
  • Excellent written and oral communication skills and interpersonal skills

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

We are seeking a Lab Software Administrator to join our Analytical R&D team at our Philadelphia location. The Lab software administrator will be responsible for administering lab GMP computer systems used in Analytical R&D lab and help to validate computer system and software. The Lab software administrator will be work with management to upgrade current computer systems and software, to acquire new computer systems and software to keep the Analytical R&D lab up to the current GMP and business requirements. Time permitting, also support other departments, such as QC lab and Compliance department on computer system and software validation and administering.

Responsibilities

Essential Functions

  • Create and maintain user accounts for Empower, Stability System II, Malvern Mastersizer 3000, and software for other stand-alone instruments;
  • Administering Empower servers, LAC/E boxes, and other computers for stand-alone instruments;
  • Resolve software and instrument computer related issues to support analytical testing in a timely manner;
  • Perform data-integrity review for all the lab computers and software per compliance requirements and company SOPs;
  • Create and validate custom fields and reports per the company needs;
  • Work with IT Department on data backup and archiving;
  • Work with Compliance Department on software and computer validation;
  • Lead and coordinator computer/software upgrade and acquisition / installation / qualification/validation of new software and computers for instruments;
  • Write/Review/Approve related SOPs;
  • Review analytical test data per company needs;
  • Help to manage lab documents in MasterControl system;
  • Other duties as assigned.

Qualifications

  • MS or BS in Chemistry, Computer, or other related scientific fields with 2+ years of related experience;
  • Experience with Waters Empower is a must;
  • Experience with Computer System Validation following GAMP desired;
  • Knowledge of cGMP and FDA regulations;
  • Excellent written and oral communication skills and interpersonal skills.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

Summary

We are seeking an Associate Scientist to join our Formulation team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation and manufacturing process development by performing formulation development, scale-up, and validation activities for both ANDA and NDA projects.

 

 

Responsibilities

Essential Functions

  • Assist Formulation Scientists in design and develop of formulations and processes for new drug products, with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
  • Assist Formulation Scientists in set-up, operation, and execution of R&D lab experiments
  • Create and follow protocol and batch records in manufacturing development batches
  • Perform laboratory assignments and evaluate testing results
  • Document experiments in lab notebooks, write experimental batch records, stability study protocols, and product development reports
  • Assist in manufacturing of development, optimization, scale-up, and submission batches
  • Help troubleshoot formulation issues that occur during R&D development, scale-ups and/or in production
  • Communicate and present results through oral and/or written updates and formal reports, as needed to internal and external project teams
  • Attend SOP, safety and scientific training’s to remain current with cGMP regulations, safety standards, and development technologies
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

Knowledge, Skills and Abilities

  • Bachelor degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, Material Science or equivalent with 0-2 years of experience.
  • Knowledge of pharmaceutical formulation development principles, QbD, CMC regulation and organization skills
  • Good interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.

Job Summary

We are seeking an experienced scientist to join our Formulation team at our Philadelphia location. This is a laboratory-based position and the candidate will be responsible to support formulation and manufacturing process development by performing formulation development activities for both ANDA and NDA projects.

Responsibilities

  •  Design and develop formulations and processes for new drug products with a focus on oral solids and suspensions for clinical trials, ANDA and NDA projects
  • Utilize experimental design to rapidly optimize formulation composition and in-process specifications
  • Evaluate product testing results, provide next steps for continued development until finalize product formulation and processes
  • Present product development progress to upper management and project teams
  • Write CGMP manufacturing batch record, stability study protocol, in-process and finished product specifications and product development reports
  • Manufacture development, optimization and scale-up batches and submission batches
  • Troubleshoot formulation issues that occur during RD development, scale-ups and/or in production
  • Effectively communicate with cross functional teams like Analytical Development, Quality, PK, Regulatory Affairs and Legal teams
  • Attend SOP, Safety and scientific trainings to remain current with CGMP regulations, safety standards, and development technologies
  • Follow relevant Frontida SOP’s and FDA/ICH guidance
  • Other duties as assigned

Qualifications

  •  Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemistry or Chemical Engineering with 0-2 years of experience or a Master’s degree with 3 years’ experience is preferred. Experience with generic drug development is desirable
  • Good understanding of pharmaceutical formulation development principles, QbD, CMC regulation and strong organization skills
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High degree of professionalism, ethics and integrity
  • Incumbent must be able to be accountable for own actions and decisions and is in compliance of the laws and company policies.
  • Willing to participate in our group identity characterized by commitment, trust, and care for each other.
  • Willing to invest time and energy in continuous improvement efforts

Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status or any other characteristic protected by law.

Frontida BioPharm, Inc., an equal opportunity employer, is located in Philadelphia, PA. Our vision is to make a positive impact on the pharmaceutical and biotechnology industries through our services. We aim to create a healthy, caring and dedicated work environment for our employees, so they can provide the highest quality healthcare products for patients. But we understand that the world is bigger than our four walls. That’s why we make it our duty to contribute to our community as individuals and as a corporation, and keep our community in mind in everything we do.