Senior Stability Specialist
Gdańsk

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

Acting as a Senior Stability Specialist in the Quality Control. Acting as a major contact point for topics related to stability study in a given project, from development to discontinuation of production. Coordinating analytical activities and compilation of quality documents on the stability of the intermediate and the final product. Managing analytical knowledge about a specific project in the context of stability studies, by communicating with all those involved in the project. Supporting the process of solving problems related to the subject of analyzes performed for the needs of stability studies. 

Your responsibilities

  • Performing paper and electronic data review associated with stability studies to ensure data integrity in the Quality Control. 
  • Ensuring proper management, compliance and integrity of Quality Control documents, such as stability: protocols, reports, results, methods, specifications etc. 
  • Supporting Quality Control in the implementation of new computerized systems, e.g. LIMS, regarding stability studies. 
  • Participation in activities improving processes related to stability studies to increase their efficiency. 
  • Supporting analytical project leads in topics related to the stability of intermediate and final product. 
  • Supporting investigation of quality records such as deviations, CAPA, Change Control, related to stability testing. 
  • Active communication of stability testing topics to relevant supervisors and their teams. 
  • Conducting training in issues related to stability studies. 
  • Participation in the preparation of Polpharma Biologics for pharmaceutical inspections and audits conducted by domestic and foreign regulatory bodies. 
  • Contact and cooperation with domestic and foreign regulatory authorities in terms of product stability and associated analysis. 

 

If you have

  • Higher education in biology, chemistry, pharmacy, biotechnology or related fields. 
  • Knowledge of GMP requirements, pharmaceutical laws and regulations for pharmaceuticals, especially for biopharmaceuticals. 
  • Minimum 5 years experience in regulated laboratory environment (preferred biotechnological lab).  
  • Very good knowledge of GLP and GDP rules. 
  • Punctuality regarding timelines, ability to prioritize tasks. 
  • Good organization of work and time. 
  • Fluent knowledge of English both, written and spoken. 
  • Very good knowledge of MS Office. 
  • Ability to solve problems independently and teamwork. 
  • Ability of analytical thinking. 

 

We offer

  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more…
Join our Team!

Why you should work with us

Contact us
[email protected]

INFORMATION ON PERSONAL DATA PROCESSING

 

 

 

By sending the data contained in the recruitment notice and the application documents (in particular the application form, CV, cover letter and references), you consent to the processing of your personal data that you have given voluntarily, other than your forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications and career history, by Polpharma Biologics S.A., with its registered office in Gdańsk, at ul. Trzy Lipy 3, 80-172 Gdańsk, which is entered into the Register of Entrepreneurs kept by the District Court for Gdańsk-Północ in Gdańsk, VII Commercial Division of the National Court Register under the registration number: 0000763945, TIN: 957-11-12-470, fully paid up share capital of: PLN 695,000,000 (hereinafter: “Employer”)for the purpose of conducting the current recruitment process, i.e. assessing your qualifications, as well as the abilities and skills that are needed for working in the specific position for which you are applying – for 12 months.

 

In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation; hereinafter “GDPR”), we would like to inform you that:

 

1.The Controller’s identity

 

 

1.1.

 

Current recruitment process

 

The controller of your personal data which is being processed in the current recruitment process is the Employer. 

 

1.2.

 

Future and other pending recruitment processes – database of candidates

 

Additionally, you may agree to your data being saved in the candidate database used by the Polpharma Biologics Group companies for 36 months.  In such a case, the Joint Controllers of your personal data will be the companies from the Polpharma Biologics Group, i.e.:

  • Polpharma Biologics S.A. with its registered office in Gdańsk, ul Trzy Lipy 3, 80-172 Gdańsk, which is entered into the register of entrepreneurs of the National Court Register, which is kept by the District Court for Gdańsk-Północ in Gdańsk, VII Commercial Division of the National Court Register under the number: 0000763945, TIN: 9571112470, waste database number: 000120346, with share capital of: PLN 695,000,000.00 (fully paid up).

 

  • Polpharma Biologics Warsaw Sp. z o.o., with its registered office in Duchnice, ul. Spółdzielcza 4, 05-850 Duchnice, postal district Ożarów Mazowiecki, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000498732, TIN: 1182096979, waste database number: 000476915, with share capital of: PLN 189,835,000.00

 

  • Polpharma Biologics Utrecht B.V. ul. Yalelaan 46, 3584 CM Utrecht, Netherlands

 

  • Polpharma Biologics Group B.V., Herengracht 458, 1017 CA Amsterdam, Netherlands.

 

(hereinafter also referred to as: the “Joint Controllers”);

 

The companies will act as Joint Controllers with regard to keeping a common database of potential job candidates of the Company mentioned above.  The database operated by them is managed by Polpharma Biologics S.A.

 

If your application is considered within future or other pending active recruitment processes, the Joint Controller conducting the recruitment will act in this respect as a separate controller, processing data on the principles described in this clause.  

 

2. Contact details

 

2.1.

Personal data protection

 

You can contact each of the controllers on all matters regarding personal data protection, in order to exercise your rights by sending an e-mail to: [email protected]

 

2.2.

Other matters regarding recruitment

 

Please contact us at [email protected] in other recruitment matters.

 

3. Objectives of and grounds for processing personal data

 

3.1.

Active recruitment process – including the current recruitment

 

a. In the case of the processing of your personal data within an active (including current) recruitment process, your personal data will be processed to hold the recruitment process that is being conducted, i.e. to assess your qualifications, as well as the abilities and skills that are needed to work in the position for which you are applying, and in order to select a suitable person for that position – on the basis of:

 

  • Article 6(1)(c) GDPR, i.e. the processing is necessary for fulfilling the controller’s legal obligation arising from the provisions of labour law (in particular Article 221 1 of the Labour Code) with regard to the following personal data: your forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications and career history;

 

  • Article 6(1)(a) GDPR, i.e. on the basis of your voluntarily given consent with regard to the other personal data you have voluntarily provided in your application documents (in particular in your CV, your cover letter and your references);

 

  • Article 6(1)(b) GDPR, i.e. processing is necessary to take steps at your request before entering into a contract (applies to recruitment for positions where the Employer enters into cooperation with the candidate on the basis of a legal relationship other than an employment relationship);

 

  • Article 6(1)(f) GDPR, i.e. the processing is necessary for the purposes of the legitimate interests pursued by the controller, because of the possibility of contacting candidates even after the end of the recruitment process, if a person who qualified for the position does not take the job or the employment contract concluded with him/her is terminated within 12 months of the end of the recruitment process;

 

  • Article 6(1)(f) GDPR, i.e. the processing is necessary for the purposes of the legitimate interests pursued by the controller – establishment, assertion or defence against possible claims between you and the data controller (with regard to all personal data you provided).

 

b. Your provision of your personal data as specified in Article 221 § 1 of the Labour Code (i.e. forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications, employment history) arises from the statutory obligation to collect such data from people applying for employment, as specified in the Labour Code. It is necessary for you to be able to participate in the active recruitment process.  The consequence of failing to provide this data is the inability to participate in the active (including the current) recruitment process. 

 

c. The provision of other personal data is voluntary and does not constitute a condition for participation in the active (including current) recruitment process.

 

 

3.2.

Processing personal data in the database of candidates

a.  If you give your consent to the processing of your data in the database of candidates for the purposes of future or other pending recruitment processes, your personal data will be processed in order to keep a database of candidates for conducting future or other pending recruitment processes, i.e. assessing your qualifications as well as the abilities and skills that are needed to work in the position for which the recruitment is being conducted, and selecting a suitable person to work in that position – on the basis of:

  • Article 6(1)(a) GDPR, i.e. your freely given consent – with respect to all personal data provided by you;

b.  The provision of your personal data and your consent to the processing of all your personal data in order to take part in future recruitment processes is voluntary, but it is a condition for the inclusion of your personal data in the above database which is kept for the purposes of future recruitment processes.

 

 

4. Categories of recipients of personal data

 

4.1.

Your personal data may be disclosed to the following entities: employees and associates of the data controller, entities handling recruitment processes for it and on its behalf, IT service providers, as well as entities providing advisory and legal services and other entities from the Polpharma Biologics Group.

 

4.2.

Your personal data may be disclosed to entities and authorities that are authorised to process such data by law.

 

4.3.

The controller does not intend to transfer your personal data to countries outside the European Economic Area or to an international organisation. However, in certain situations related to personal data processing, data may be transferred outside the EEA. Personal data may only be transferred outside the EU or EEA either to countries that the European Commission has found to guarantee an adequate level of data protection or with appropriate safeguards, in particular through the use of EU Standard Contractual Clauses.  In such cases, you may request a copy of these respective safeguards, in particular the EU Standard Contractual Clauses (if applicable), or the specification of where your data has been sent, by writing to: [email protected]

 

5. Period of personal data storage

 

5.1.

Active recruitment process – including the current recruitment

a.  Your personal data will be processed:

  • for 12 months from the date of your application being considered for the particular recruitment process or
  • until you raise an objection which is accepted (if the processing is based on the controller’s legitimate interest) or until you withdraw your consent (if the processing is based on the consent that has been given)

 

whichever is the earlier.

 

 

5.2.

Processing personal data in the database of candidates

 

a.  Your personal data will be processed:

 

  • for 36 months from the date of your consent to the processing of your personal data for future recruitment processes

 

  • until you withdraw your consent

 

whichever is the earlier.

 

6. Rights

 

6.1.

You have the right to access your personal data and to demand its rectification, erasure or the restriction of its processing.

 

6.2.

You have the right of data portability, i.e. to receive your personal data, which you have provided to the personal data controller, in a structured, commonly used and machine-readable format. You may request the data controller to send this data to another controller.

 

6.3.

To the extent to which the processing of your personal data is based on your consent, you have the right to withdraw that consent. The withdrawal of consent shall be without prejudice to the lawfulness of the processing that was conducted on the basis of the consent before its withdrawal.

 

6.4.

You have the right to object to the processing of your personal data to the extent to which the basis for the processing of your personal data is a premise of the legally justified interest of the data controller.

 

6.5. 

 

You may contact the data controller to exercise the above rights by sending an e-mail to: [email protected]

 

6.6.

 

You have the right to file a complaint with the personal data protection supervisory authority (the president of the Personal Data Protection Office – Prezes Urzędu Ochrony Danych Osobowych) if you believe that the processing of your data is breaching the provisions of the law.

 

7. References

 

7.1.

 

If you provide information to us about other people, such as contact details for people who can provide references, you declare that these people have been informed of this and that they agree to the provision of their details.

 

7.2. 

 

If you are the designated contact person for providing references for the job candidate, your personal data, such as contact details will be processed for the purpose of obtaining information on the candidate’s qualifications under Article 6(1)(f), i.e. the legitimate interest of the controller, on the terms specified in this document (with the exception of the provisions of clause 3). We may also process information related to your credentials – such as the place of your employment, information about your professional relationship with / knowledge of the candidate and your opinions about him/her. We may obtain this information directly from you, from the candidate or from publicly available sources.  If we obtain data directly from you, the provision of such data is voluntary. 

 

8. Automated decision-making

 

8.1

 

No decisions will be made with respect to you in an automated manner, including as a result of profiling.